MAUDE Adverse Event Report: RICHARD WOLF GMBH; HF CONNECTION CABLE MONO L 5M

Model Number	815053
Medical Device Problem Codes	Sparking (2595); Electrical Shorting (2926)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user has not yet sent the instrument to richard wolf for examination.As soon as the instrument arrived, the examination will be started.
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding a hf connection cable mono l 5m, part id: 815.053, sn/batch# unknown.According to the received information, during resection of the bladder tumor, wolf cautery cord exploded in half and released sparks.There was no prolongation of the operation time nor any danger to the patient.

• Common Device Name: HF CONNECTION CABLE MONO L 5M
• 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18121718
• Report Number: 9611102-2023-00067
• Device Sequence Number: 17896658
• Product Code: GEI
• UDI-Device Identifier: 04055207000274
• UDI-Public: 04055207000274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2023

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: Health Professional
• Device Model Number: 815053
• Device Catalogue Number: 815.053
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 11/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown