MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; HF BIPOLAR CONNECTING CABLE L 3M

Model Number	8108232
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue regarding a hf bipolar connecting cable l 3m, part id: 8108.232, batch # unknown.According to the received information, the bipolar connecting cable failed during the case."during procedure using the erbe machine for operative portion of procedure, the princess bipolar cord made a loud noise while inside the patient.We saw the portion of the cord that was outside the patient was severed into two pieces.".Smoke at the area of the broken cord was noted by the surgeon.There was a reported 15 minutes delay in the procedure.However, the surgeon made the decision to use alternative device to finish case.According to the user facility, there was no injury to the patient and the 15 minutes delay did not put the patient at risk.
Additional Manufacturer Narrative
The following fields have new information: b4, d4 (lot #), d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), h7, and h10.The user facility was contacted several times in an effort to collect patient information and user information.Richard wolf medical instruments corp.(rwmic) has not received any response.The hf bipolar connecting cable l 3m, part id: 8108.232, lot # 7/16 was investigated by the responsible department at rwmic.The user facility has reported that the cord was broken into two pieces while the instrument was in use.During the evaluation of the device, it was determined that the cable seems to be worn from wear and tear.The strands appears to be broken due to fatigue.The probable root cause of the failure clearly indicates a weakening or breakdown of its materials due to a wear problem.Richard wolf has received 4 complaints including the current complaint (23-00073) regarding the bipolar cord 8108.232 between 01/jan/2020 and 04/jan/2024.The devices from previous complaints recorded sporadic failure of the cord due to cleaning / maintenance failure.No patient involvement was reported.In general, the user is advised in the relevant ifu ga-d 342 / en / index: 04-10-7.0 / äm: pdi 10-4213 about the checks of the cord before and after each use in section 8.1.1 for possible damage to the insulation, cable, and plug.As well as warning in section 7.2.3, "do not use and do not repair a defective cable.Replace defective cable.".

• Brand Name: SHARK/S-LINE
• Common Device Name: HF BIPOLAR CONNECTING CABLE L 3M
• 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: zsófia bartholome-nagy ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16966912
• Report Number: 9611102-2023-00026
• Device Sequence Number: 20144606
• Product Code: FAS
• UDI-Device Identifier: 04055207000908
• UDI-Public: 04055207000908
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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: 8108232
• Device Catalogue Number: 8108.232
• Device Lot Number: 7/16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown