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

Model Number 8108232

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/11/2023

Event Type  malfunction  

Event 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
• Type of Device: HF BIPOLAR CONNECTING CABLE L 3M
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 16966640
• MDR Text Key: 315915979
• Report Number: 1418479-2023-00008
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 04055207000908
• UDI-Public: 04055207000908
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 05/19/2023
• Distributor Facility Aware Date: 04/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Patient Sequence Number: 1