Important Safety Information
ReTrace® Ureteral Access Sheath Brief Statement
Indications
To establish a continuous conduit during urological endoscopic procedures facilitating the in and out passage of endoscopes and other instruments into the urinary tract.
Contraindications
All usual contraindications to ureteroscopic procedures. Any known allergies to the medical device materials. The evaluation of the allergic background of a patient is the health care professional’s responsibility.
Warnings and Precautions
Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient.
The risks and benefits of using ReTrace® ureteral access sheath should be considered in patients.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Minneapolis, MN
03/19/2021 PM-15964
Coloplast TFL Drive Brief Statement
Indications
The Coloplast TFL Drive laser device and its accessories are intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue with or without an endoscope, in the following indications: Urology, Lithotripsy, Gastroenterological Surgery and Gynecological Surgery.
Contraindications
The use of the laser is contraindicated:
- In patients whose general medical condition contraindicates surgical intervention.
- When appropriate anaesthesia is contraindicated by patient history or inability to receive anesthesia.
- Where tissue (especially tumors) is calcified.
- For hemostasis of vessels with diameters over approximately two millimeters.
- Where laser therapy is not considered the treatment of choice.
- In patients who have recently undergone radiotherapy. Such patients may be at greater risk of tissue perforation or erosion.
- In patients unable to receive endoscopic treatment.
- In patient suffering from bleeding disorders and coagulopathy.
- Diagnosed with acute or chronic prostatitis, prostate cancer, or severe urethral stricture.
- Diagnosed at the time of treatment with acute or chronic urinary tract infection.
- Patients with compromised renal function or upper urinary tract obstructive diseases.
- Patients who still wish to have children.
- Patients with an ASA classification of physical status 5.
- Patients with a prostate gland > 120g.
Warnings and Precautions
Clinical studies have shown that patients who have undergone radiation therapy present a greater risk of perforation or tissue erosion. The Coloplast Drive Laser System is a surgical device that should be used only by physicians or surgeons who have been thoroughly trained in laser surgery. Surgeons using Coloplast TFL Drive Laser System must understand the laser’s unique properties prior to using the device.
As with conventional endoscopic surgery, the possibility of complications and adverse events (such as chills, fever, edema, hemorrhage, inflammation, tissue necrosis or infection) may occur following treatment. In extreme cases, death may occur due to procedural complications or concurrent illness. The laser may not be effective for coagulation in massive haemorrhage situations. The surgeon must be prepared to control haemorrhages with alternative non-laser techniques, such as ligature or cautery. The risk of infection and scarring associated with any surgical procedure has to be taken into account. Tissue perforation may result if excessive laser energy is applied. This could occur through the use of excessive laser power or the application of a correct power for excessive periods, particularly in diseased tissue. The use of mechanical pressure on the Single-Use and Reusable Optical Fiber devices does not increase its cutting or vaporization effects but may induce bleeding, thermal damage and fiber destruction.
The manufacturer has no clinical information or experience concerning the use of the Laser System on pregnant women or nursing mothers. There is no guarantee that treatment with the Laser System will entirely eliminate the disease. Repeated treatment or alternative therapies may subsequently be required.
Potential Complications
Complications and risks are the same of the conventional laser surgery. Acute pain may occur immediately following laser therapy and may persist for as long as 48 hours. Immediately following laser therapy, the patient may experience fever and leucocytosis, which are commonly associated with tissue destruction. These generally resolve without treatment. Laser ablated tissue may become necrotic or infected after treatment. In case of concerns about any possible infection, appropriate treatment should be carried out.
Acute complications and non-thermal risks include induced hemorrhage, ulceration, perforation, edema, pain, fever, leukocytosis, and chills. Critical complications and thermal risks include healing delay, perforation, stenosis, delayed hemorrhage, sepsis, and embolism.
The following complications could be serious and could result in death:
- Patients may experience bleeding at the site of laser therapy. Haematocrit analysis after treatment is recommended to identify this potential complication.
- Sepsis can result from performing any surgical procedure. In case of concerns about any possible sepsis, appropriate evaluations should be made.
- Perforation may occur as a result of laser treatment. In order to diagnose perforations, patients must be carefully followed post-operatively with appropriate tests.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Minneapolis, MN
6/27/2022 PM-21981
Coloplast TFL Drive Laser Fibers Brief Statement
Indications – Single Use Lateral and 150μm Optical Fibers
Single Use Lateral and 150μm Optical Fibers are intended to be used to deliver the laser radiation to the target tissue when used with any cleared/certified surgical laser with operational wavelengths between 532 nm – 2200 nm equipped with SMA 905 or SMA 906 or compatible connector, as per the indications of the laser device used with.
Indications – Single Use and Reusable Optical Fibers
Single Use and Reusable Optical Fibers are intended to be used in conjunction with any cleared surgical laser distributed by Coloplast equipped with SMA 905 or SMA 906 or compatible connector for use in general surgical applications (incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in contact or non-contact mode). Optical Fibers are also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated.
The Optical Fibers are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis. Optical Fibers are also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue, and for use in lithotripsy.
Optical Fibers are indicated for use with laser devices emitting radiation from 532 nm to 2100 nm, with pulsed and continuous wave (CW) emission mode, and, but not limited, for use with Diode laser, Argon, KTP/532, Ho:YAG, Nd:YAG, Tm:YAG pulsed and continuous wave CW laser devices.
Optical Fibers may be used in surgical specialties or procedures for which compatible lasers have received regulatory clearance: for a complete information about applications, contraindications, precautions and warnings when using Optical Fibers it is necessary to refer to the applicable laser device User Manual.
Warnings and Precautions – Single Use, Single Use 150μm and Reusable Optical Fibers
Optical Fibers shall be used by trained and qualified users only. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to a device failure which, in turn, may result in patient injury, illness or death (For Single Use Fibers Only). On patients with confirmed or suspected Transmissible spongiform encephalopathies (TSEs), also known as prion disease, use only Single-use Sterile Optical fibers.
Potential Complications – Single Use, Single Use 150μm and Reusable Optical Fibers
Complications that could occur during laser treatments include local and/or systemic infection, thermal changes to the surrounding structures, local hematoma, dissection and perforation, tissue adhesion, distal tip detachment, and discomfort during and/or after (laser) energy application. In the unlikely event of a detached tip, it may be visually located through an appropriate scope and removed using forceps. Irrigate the area thoroughly to remove any traces of the tip.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Minneapolis, MN
7/14/2022 PM-21989
Dormia® No-Tip Brief Statement
Indications
Extraction of urinary tract calculi.
Contraindications
Any conditions contraindicating the use of a stone extractor. Any known allergies to the medical device materials. Extraction of biliary duct calculi.
Warnings and Precautions
This type of instrument must only be used by trained and experienced professionals.
Adverse Events
Lesions of the urinary tract if the operating procedure and the warnings set out below are not observed.
The risks and benefits of using Dormia® No-Tip should be considered in patients.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Minneapolis, MN
05/17/2021 PM-16911
Imajin® Silicone Hydrocoated Double Loop Ureteral Stent Kit Brief Statement
Indications
Drainage of the upper urinary tract over fistulas or ureteral obstacles. Healing of the Ureter. Cicatrisation stent.
Contraindications
Untreated progressive infection of the upper urinary tract. Any known allergies to the medical device materials. These devices may particularly contain traces of silicone resulting from the manufacturing process. The evaluation of the allergic background of a patient is the healthcare professional’s responsibility. Do not attempt stent placement in a patient with suspect ureteral avulsion. Do not use, when, in the judgement of the physician, such a procedure would be contrary to the best interest of the patient.
Warnings and Precautions
Reuse of this single use product may create a potential risk to the user. Reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient. Formation of knots in lengthy stents have been reported as adverse events and may require surgical intervention to remove them.
Adverse Events
The following events have been reported although their occurrence greatly depends on patients’ medical conditions. Adverse events include but are not limited to: migration or dislodgement, encrustation, infection, fragmentation, flank pain, mucosal irritation or inflammation, mucus secretion, frequency, urgency, dysuria, hematuria, reflux, stone formation, obstruction, erosion and perforation of the renal pelvis, ureter or bladder. Some events may be related to this procedure, amongst which those related to the guidewire: ureteral perforation, or burns when in contact with an electrosurgical equipment.
The risks and benefits of using Imajin® Silicone Hydrocoated Double Loop Ureteral Stent Kits should be considered in patients.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Minneapolis, MN
03/19/2021 PM-15976
ISIRIS® Stent Removal Brief Statement
Indications
Isiris is a sterile single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via an urethral insertion in adults. Isiris has been designed to be used with the reusable Isiris monitor to visualize the observations obtained by Isiris.
Warnings and Precautions
Do not use active endoscopic accessories such as laser probes and electrosurgical equipment in conjunction with the Isiris system, as this may result in patient injury or damage to the Isiris system. Alert the user to the possibility of injury, death, or other serious adverse reactions associated with the use or misuse of the Isiris system. The Isiris system is neither MRI safe nor MRI compatible. Do not use the Isiris system during defibrillation. Only to be used by skilled physicians trained in clinical endoscopic techniques and procedures. Passive deflection and retrovision maneuvers may be hazardous as it may affect the device, especially the grasper functionality. The distal end of the endoscope may get warm due to heating from the light emission part. Avoid long periods of contact between the tip of the device and the mucosal membrane as long, sustained contact with the mucosal membrane may cause mucosal injury. Do not enter any part of Isiris into the ureter. Do not activate the grasper when the distal end is inside the urethra. Do not activate the grasper during suctioning. Do not attempt to clean and reuse Isiris as it is a single-use device. Reuse of the product can cause contamination, leading to infections.
The risks and benefits of using ISIRIS® stent removal should be considered in patients.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.
Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Minneapolis, MN
05/06/2021 PM-16719
References
- Sugihara T, Yasunaga H, Horiguchi H, Nishimatsu H, Kume H, Ohe K, et al. A nomogram predicting severe adverse events after ureteroscopic lithotripsy: 12 372 patients in a Japanese national series. BJU Int. 2013;111(3):459–66. https://doi.org/10.1111/j. 1464-410X.2012.11594.x.
- Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93. PMID: 11176469.
- Childers C., Maggard-Gibbons, M. Understanding Costs of Care in the Operating Room. JAMA Surgery 2018; Vol. 153;4
- Martov A., Ergakov D., Guseynov M., Andronov A., Plekhanova O.A. Clinical Comparison of Super Pulse Thulium Fiber Laser and High-Power Holmium Laser for Ureteral Stone Management. J. Endourol. 2020:795-800. doi: 10.1089/end.2020.0581
- Ozgor, F., Sahan, M., Cubuk, A. et al. Factors affecting infectious complications following flexible ureterorenoscopy. Urolithiasis 47, 481–486 (2019). https://doi.org/10.1007/s00240-018-1098-y
- Carey, R. et al. Frequency of Ureteroscope Damage seen at a tertiary care center. Journal of Urology. 2006; 176 (2). 607-610.
- PharmacoEcon Outcomes News 889, 25 (2021). https://doi.org/10.1007/s40274-021-08113-1
- Bench Test performed by Coloplast. Data on file with Coloplast.
- Geavlete, P., Georgescu, D., Multescu, R., Stanscu, F. et al. Ureteral stent complications- experience on 50,000 procedures. Journal of Medicine and Life. 2021;14 (6): 769-774.
- Wiseman O, Ventimiglia E, Doizi S, et al. Effects of silicone hydrocoated double loop ureteral stent on symptoms and quality of life in patients undergoing flexible ureteroscopy for kidney stone: a randomized multicenter clinical study. J Urol. 2020;204(4):769-777. doi:10.1097/JU.0000000000001098
- Barghouthy, Y., Wiseman, O., Ventimiglia, E. et al. Silicone-hydrocoated ureteral stents encrustation and biofilm formation after 3-week dwell time: results of a prospective randomized multicenter clinical study. World J Urol 39, 3623–3629 (2021). https://doi.org/10.1007/s00345-021-03646-0
- Kenigsberg, et. al., “The Economics of a Cystoscopy: A microcost Analysis…”
- Pietropaolo A, Hughes T, Tear L, Somani BK. Comparison of ureteric stent removal procedures using reusable and single-use flexible cystoscopes following ureteroscopy and lasertripsy: a micro cost analysis. Cent European J Urol. 2020; 73: 342-348.
- Carneiro A. (2020) Same sized three-way indwelling urinary catheters from various manufacturers present different irrigation and drainage properties. Therapeutic Advances in Urology, 7.
- Bench Test performed by Coloplast. Data on file with Coloplast.
