MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT PASSIVE BIPO 0/12/30°

Model Number	8680225
Medical Device Problem Codes	Overheating of Device (1437); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The working element passive bipo 0/12/30°, part id: 8680.225, lot # 1285560 was investigated at richard wolf medical instruments corporation (rwmic).The investigation findings confirmed traces of burns inside electrode lock housing at both h.F.Connecting post and electrode lock connector.The metal of electrode lock connector was burnt and partially melted.Burnt debris were found inside.Also, there were burns on inner surface of scope guide shaft.Further investigations revealed that the damage was most likely the result of an excessively high current which super-heated the metal and adhesives in the device.This existing evidence is not sufficient to confirm the exact cause of the event.An evaluation of the history of the device has shown that this working element with the batch number 1285560 was produced on july 8, 2015.There were no anomalies during production and all parts passed the functional test.The complaints database from 01/oct/2015 until 18/jan/2024 has shown that there are a total of 2 similar complaints distributed over different batches.· (b)(4): 2/3/2023: mdr 9611102-2023-00019, batch# 1474987 · (b)(4): 10/19/2023: mdr 9611102-2023-00065, batch# 1499179 in the same period, (b)(4) units were sold, which corresponds to a frequency of (b)(4)% for similar complaints.In this current case with the affected batch no.1285560 there was a 2nd complaint, but with different reason.On 14/oct/2016, the following complaint was submitted (b)(4), reason for the complaint: breakage of the cable connection.This fault was addressed as "not traceable", as a fixing screw was missing.A general product problem can be excluded.In general, the user is advised in the associated instructions for use, ga-d342 / en / us / v11.0 / 2023-08 / pk23-0156 (rw: en / 2021-03 v16.0 / pk20-0295), under chapter 7 use - warning: hazard due to line voltage! caution: hf devices generate high-frequency electrical voltages and currents as intended.In order to avoid such damages, chapter 8, recommends that a visual and functional check must be carried out before and after each use.Do not use the products if they are damaged and incomplete or have loose parts.With regard to the hf bipolar connection cable, chapter 8.1.1, states to check for damage to the insulation and/or the cable / plug, e.G., cracks and breaks.Under chapter 8.1.4 electrodes, to check the insulation and replace the electrodes in the event of damage or distal wear.Possible hazards were considered in the risk assessment b6-11 rev.04 with the corresponding extent of damage and probability of occurrence under "hazards due to non-usable product" under "handling-related" and assessed as acceptable.
Event or Problem Description
A user facility has informed richard medical instruments corporation (rwmic) of an issue regarding a working element passive bipo 0/12/30°, part id: 8680.225, lot# 1285560.According to the received information, at the beginning of a transurethral resection of bladder tumor the medical doctor, registered nurse, and surgical technologist reported a loud pop from the device occurred while in the physician's hand.This caused a few minutes delay during the operation.A back-up device was retrieved to complete the scheduled procedure.There is no report of injury to the patient or other personnel.

• Brand Name: S-LINE
• Common Device Name: WORKING ELEMENT PASSIVE BIPO 0/12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18660542
• Report Number: 9611102-2024-00003
• Device Sequence Number: 17863774
• Product Code: FDC
• UDI-Device Identifier: 04055207042953
• UDI-Public: 04055207042953
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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
• Operator of Device: Other
• Device Model Number: 8680225
• Device Catalogue Number: 8680.225
• Device Lot Number: 1285560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART ID: 46221313US - CUTTING ELECTRODE BIPO 24FR
• Patient Sex: Unknown