MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; CUTTING ELECTRODE BIPO 24FR 12/30°

Model Number 8622131

Device Problems Material Disintegration (1177); Overheating of Device (1437)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Richard wolf gmbh complaint reference: (b)(4).During resection of a bladder neck stenosis with the martin hf generator and a 24ch resectoscope, the loop was burnt out during application.The settings were as usual - pma/510k with flash without dots, coagulation 180.The application with a new disposable snare was without problems.The individual pieces of metal could be recovered, rinsed out.Surgery time extension 15 minutes.Rwgmbh awareness date, 22-aug-2022.

Manufacturer Narrative

Richard wolf medical instruments corporation (rwmic) is submitting this report on behalf of rwgmbh.Rwgmbh considers this matter open.However, in the event rwgmbh receives any additional information a follow up report will be submitted to fda.

Event Description

Richard wolf gmbh complaint reference number: (b)(4) (fu1 mdr / device evaluation).The purpose of this submission is to report the results of the device evaluation.Device evaluation: rwgmbh awareness date, 09-jan-2023.

Manufacturer Narrative

Follow-up report #1 is to provide fda with device evaluation information about this mdr.New information: h6 (clinical and impact code, type of investigation, investigation findings, investigation conclusions).The incident questionnaire of 24.08.2022 states the following: resection of a bladder neck stenosis with the martin device (hf generator) and a resectoscope 24ch shows a "bursting" or "explosion" of the resection sling.The settings were as usual - g4 with flash without dots, coagulation 180.The application with a new disposable snare was without problems.The application with a new disposable snare was carried out without any problems.The individual pieces of metal could be recovered or flushed out.Due to the incident, the operating time was extended by 15 minutes.The patient's condition after the procedure was described as stable.No unscheduled medical measures had to be taken.Information on the previous number of reprocessing's and applications of the reusable electrode 8622131 is not available.The power settings specified by the user on the hf generator (martin) are in accordance with the rated voltage of this electrode specified in the ga-d342 instructions for use.The electrode will basically function with these settings.The bipolar multi-use cutting electrode 8622131 sent in shows distal severe damage at the ends of the guide tube.This shows a strong heat effect which leads to melting and separation of the guide tube.The electrode loop itself is no longer present.At the rear end of the metal guide tube, it is evident that the electrode has been displaced proximally.The distance between the electrode loop and the guide tube is thus shortened.The 8622131 cutting electrode bipo 24fr 12/30° has been in stock since 2008-11-13.The cutting electrodes with the batch: 1498295 were booked into stock on 27/01/2022 with a batch size of (b)(4) pieces.(b)(4) units from the batch in question were delivered to the hospital on 10.03.2022 and (b)(4) units on 21.03.2022.As of 01.09.2022, no further electrodes from batch: 1498295 were complained about.In a current series of tests, the force required to move the guide tube was determined for 6 cutting electrodes from 4 lots.The force required for displacement was above the defined limit value for all electrodes.The application of a greater force by the user is considered improper handling.The following applicable warnings for this error are described in the instructions for use ga-d342 / en / 2021-03 v16.0 / pk20-0295: 7 use.Warning: the products have only limited strength! exerting excessive force will cause damage, impair the function, and therefore endanger the patient.Always hold the cable by the plug when plugging and unplugging; never pull on the hf cable.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: risk of hf arcing! too small a distance between high-frequency current-carrying parts and other conductive parts, as well as significant heat generation, can lead to unintentional damage to the tissue and to damage of the ceramic on the sheath and on the endoscope.Activate high-frequency current-carrying parts of hf instruments only in the extended state (fig.23).In the event of hf arcing, replace the electrode immediately, check the endoscope for damage, and, if necessary, send in for repair to prevent consequential damage.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.Possible hazards due to thermal energy were considered in the risk assessment b2-3, rev.04 with the corresponding extent of damage and probability of occurrence.This assessment remains valid even after taking the new case into account.In summary, the information provided by the customer and the damage pattern suggest that improper handling has occurred (user error).To counteract this, the user is informed in the corresponding instructions for use about the checks to be carried out before and after each application.In addition, the user is advised not to use any damaged products.The short-circuit could have been avoided by taking these instructions into account.Based on the above findings and the fact that there are no indications of a product or charging problem, no measures are considered necessary.

• Brand Name: S-LINE
• Type of Device: CUTTING ELECTRODE BIPO 24FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; 75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• Manufacturer Contact: oliver ehlrich ; pforzheimer strasse 22; 75438 knittlingen, germany ; GM
• MDR Report Key: 15461800
• MDR Text Key: 306178553
• Report Number: 9611102-2022-00046
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207018019
• UDI-Public: 04055207018019
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8622131
• Device Catalogue Number: 8622131
• Device Lot Number: 1498295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other