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.

• 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
• MDR Report Key: 16966640
• Report Number: 1418479-2023-00008
• Device Sequence Number: 14800598
• 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: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2023
• Report Date (Section F): 05/19/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/19/2023