MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; WORKING ELEMENT PASSIVE MONO

Model Number 8674225

Device Problems Break (1069); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint open.Rwmic will submit a follow up report with additional information and investigation of this complaint.Note: this mdr was mistakenly submitted under report 1418479-2020-00265.The correct report number under which this complaint will be traced and investigated is 1418479-2020-00039.

Event Description

On october 5th , 2020, the user facility reported the following to richard wolf medical instruments corporation (rwmic): the loops were completely burning out and breaking during a turp- we went through 5 different loops in one case and it ended up charring the end of the sheath which led to bits of metal breaking off into the patients body will the device be returned? yes was the device being used during a procedure when the issue occurred? yes was there any injury or illness to the patient due to the reported issue? no was there any injury or illness to any other personnel due to the reported issue? no did the issue cause a delay in the procedure being performed? yes did the delay put the patient at risk? (only applicable if there was a report of delay) unknown was there a similar back-up device available for use? yes was the scheduled procedure completed? yes note: this mdr was mistakenly submitted under report 1418479-2020-00265.The correct report number under which this complaint will be traced and investigated is 1418479-2020-00039.

Event Description

On february 4th, 2021, rwmic received the following information from the sales rep: in discussions with the user facility and the doctor it was determined that it was a medtronic generator causing the issue.The customer was having to use 3-4 loops per turp.We exchanged out the generator in the cysto room and found it was the medtronic generator that was causing the loops to burn out.The customer has send the medtronic generator for repair and is using one out of another room.

Manufacturer Narrative

Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.On february 4th, 2021, rwmic received new information from the initial reporter.According to the user facility, rwmic products were used with a medtronic generator which was causing the issue.Labeling review (ifu: ga-d366): caution! do not combine products incorrectly! injuries of the patient, user or others as well as damage to the product are possible.The different products may only be used together if their intended uses and the relevant technical data (working length, diameter, peak voltage, etc.) are the same.Follow the instruction manuals of the products used in combination with this product.Follow the "notes and instructions on hf applications", order no.: ga-s 002 as well as the hf device manufacturer's instructions.Caution! the products have only limited strength! excessive force will cause damage, impair the function and therefore endanger the patient.Immediately before and after each use, check the products for damage, loose parts and completeness.Make sure that no missing parts remain in the patient.Do not use the products if they are damaged or incomplete or have loose parts.Warning! danger of electric shock! patient leakage currents can add up if the endoscopes are combined with other powered endoscopic accessories.Make sure that the combinations do not exceed the permissible patient leakage currents.Caution! careful if hf voltage is too high! danger of injury resulting from damage to the electrode insulation! exceeding the maximum recurring peak voltage for the electrode in combination with hf surgical devices and / or selecting the wrong mode can destroy the insulation and cause leakage currents.The patient, user or others may suffer tissue damage! use electrodes in conjunction with hf surgical devices only at a recurring peak voltage of max.2 kv, even in forced or spray coagulation.We recommend using the following power settings: single-use electrodes.Cutting mode: 120 - 180 watt.Coagulation mode: maximum 100 watts.Caution! careful if hf output power is incorrectly selected! injuries of the patient as well as damage to the product are possible.The power should be set on the basis of the surgeon's experience and training in view of the corresponding indication.Rwmic considers this mdr and complaint closed at this time.If additional information become available, a follow up report will be submitted.

Event Description

The purpose of this reports is to share the results of the device investigation/evaluation.The device was received and visually inspected.The reported condition - loops were completely burning - was confirmed during evaluation.The probable root cause was thought to be user error.The manfacturer reports the following findings: after consultation with the user, it was determined that the electrodes were used with a medtronic generator.This caused the user to use 3-4 electrodes per turp.The generator was replaced and it was determined that the medtronic generator was causing the loops to burn out completely.According to the supplement bb-d366, system overview "shark" resectoscopes, the system components listed in the tables must only be used in compliance with the ga-d366 instruction for use.In general, the user is advied in the corresponding instructions for use ga-d366/en/2018-03 v5.0/pk 18-9297 under chapter 8 that a visual and functional check must be carried out before each use.Do not use products that are damaged, incomplete or have loose parts.Possible damage or deviations can be easily detected by hospital personnel.The device was scrapped.

Manufacturer Narrative

Follow-up report #2 is to provide fda with missing information, new information, and changed information and the results of the device investigation.Rwmic is submitting this report on behalf of richard wolf gmbh.Richard wolf medical instruments corporation is the importer of this device.Rwmic considers this mdr/complaint closed.Rwmic will submit a follow up report if new information becomes available.

• Brand Name: SHARK
• Type of Device: WORKING ELEMENT PASSIVE MONO
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer street 32; knittlingen, 75438 ; GM 75438
• MDR Report Key: 10758869
• MDR Text Key: 214802178
• Report Number: 1418479-2020-00039
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207056714
• UDI-Public: 04055207056714
• Combination Product (y/n): Y
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8674225
• Device Catalogue Number: 8674225
• Device Lot Number: 1447623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 10/06/2020; 09/22/2021
• Supplement Dates FDA Received: 02/16/2021; 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1