MAUDE Adverse Event Report: RICHARD WOLF GMBH CUTTING ELECTRODE BIPO 22FR 12/30°

Model Number 8622133

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The instrument has not yet been sent for examination by the user.As soon as the examination is completed, we will send a follow-up report.

Event Description

On november 29, 2021 richard wolf was informed by the customer.The customer has reported that the loop came loose in the uterus during a resection.The loop was recovered and the electrode was kept for technical expertise if necessary.The richard wolf (b)(4) was replaced, but the treatment could not be completed.Consequences for patient, user or other person is that a new surgery is possible.

Event Description

See manufacturers narrative for results of the device investigation.

Manufacturer Narrative

Follow-up report #1 is to provide fda with any new information (results of the device investigation/evaluation) and/or changed information.The manufacturer, richard wolf gmbh, reports: the customer has sent an updated report on january 10, 2022.The customer stated there was no other device available, so the treatment could not be completed.The patient's outcome was no direct injury, but there was a delay to collect the broken piece and a new treatment is necessary.No further information about the settings of the hf generator or the duration of use was communicated.The electrode was investigated and shows a bilateral fracture at the distal loop.The broken loop was not available for investigation, but the customer stated he recovered it.On the fractures of the still existing ends of the loop there are thermal influences visible.An electrical breakdown test of the electrode resulted no further defects.In addition, the proximal part of the electrode is bent.The results of the investigations indicate a mechanical overload with additional thermal influence by high frequency application.High power settings on the hf generator can cause rapid wear and tear.Together with excessive force exerted by the user, mechanical failure of the loop may occur.The user is therefore advised in the instructions for use to keep the power settings low and the application of force low.The 8622133 cutting electrode bipo 22fr 12/30° has been in the programme since 25.11.2008.From the lot 1442390 a total of (b)(4) were booked into stock on 26.03.2020.Richard wolf france has received 10 pieces of the product from the affected lot.The production control plan was reviewed, but there are no indications for a production problem.The instructions for use ga-d342 / en / 2021-03 v16.0 / pk20-0295 / points out the following: 7 use: [.] caution! the products have only limited strength! exerting 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.7.2.4 hf application: [.] warning! incorrect selection of the hf output power! injuries to the patient, as well as damage to the product are possible.The power setting must adjusted in accordance with the operator's experience / training with reference to the applicable indication.[.] warning! risk of injury in the sphincter / cervical region! if the power settings exceed the value recommended by the hf device manufacturer, there is an increased risk of thermal damage and abrasion as well as a risk of breakage of the electrode bracket (wire).Greater irritation of the obturator nerve is also possible in this case, and the resulting twitching may promote unintentional perforation.Set power settings according to the value specified by the hf device manufacturer.The depth effect (necrosis) is about 0.5 to 2 mm, depending on the power / mode of the electrode.Therefore, be especially careful near the sphincter / cervix and use the lowest possible hf power.A dark brown coloration or carbonization of the tissue indicates excessive power.[.] caution! excessive power setting may lead to significantly higher electrode wear.To determine the optimum power setting, we recommend starting with a low power setting.8 checks: [.] warning! injuries due to damaged or incomplete products! injuries to the patient, user, and others are possible.Do not use the products if they are damaged and incomplete or have loose parts.Run through the checks before and after each use.In the risk assessment b2-3 reusable resecting electrodes rev.4, production-related, handling and design hazards with regard to a functional impairment as well as risks from a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and evaluated with an acceptable risk.Hazard (2): 5.8.5 mechanical energy.Function/component (1): 3.4 distal ending.Causes (1): 5.4 handling-related : 5.4.8 wear-increasing application.Harms (3): additional procedure.Since no new risks have arisen from the investigation of the current complaint case, the risk assessment remains valid in view of the facts described.As a conclusion, the correct selection of power settings, mode of the hf generator and the applied force in contact with tissue are an essential point in the application of bipolar resection.But, as those information are not available, a final assessment cannot be made.However, the customer was able to confirm the patient's outcome was not negative and the broken piece could be recovered.Richard wolf gmbh considers this matter closed.However, in the event rwgmbh receives any additional information a follow-up report will be submitted to fda.Richard wolf medical instruments corporation (rwmic) is submitting the report on behalf of rwgmbh.

• Brand Name: CUTTING ELECTRODE BIPO 22FR 12/30°
• Type of Device: ELECTRODE
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer str. 32; knittlingen,, baden-wurtemberg 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer str. 32; knittlingen,, baden-wurtemberg 75438 ; GM 75438
• Manufacturer Contact: phillipp schmidt ; pforzheimer str. 32; knittlingen,, baden-wurtemberg 75438 ; GM 75438
• MDR Report Key: 13091000
• MDR Text Key: 284974416
• Report Number: 9611102-2021-00041
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207018026
• UDI-Public: 04055207018026
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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: Other
• Device Model Number: 8622133
• Device Catalogue Number: 8622133
• Device Lot Number: 1442390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2021
• Supplement Dates Manufacturer Received: 01/27/2022
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other