MAUDE Adverse Event Report: RICHARD WOLF GMBH; HF CONNECTION CABLE MONO L 3M

Model Number	8106033
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) received a medwatch report, mw5153308 regarding an issue with a hf connection cable mono l 3m, part id: 8106.033, batch # 442/771.The medwatch report, mw5153308, states that the, "bovie cord sparked and exploded while in use in the operating room during patient surgery.Patient nor staff were not harmed, but a very hig potential for catastrophic or fire." according to the received information, while physician was using endo shears connected to monopolar cautery cord, suddenly the connection point of the cord and instrument sparked and broke.The cord was immediately unplugged and removed from surgical field, along with the endo shears.There was a 10 minutes delay to retrieve a new endo shears and a monopolar cord.The back-up device was then plugged into the same unit with no further complications for the remainder of this case.There is no report of injury to the patient or other personnel.

• Common Device Name: HF CONNECTION CABLE MONO 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 19268491
• Report Number: 9611102-2024-00016
• Device Sequence Number: 20578258
• Product Code: GEI
• UDI-Device Identifier: 04055207000694
• UDI-Public: 04055207000694
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K982677
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Distributor
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/08/2024

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: 8106033
• Device Catalogue Number: 8106.033
• Device Lot Number: 442/771
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Hispanic