MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; CUTTING ELECTRODE BIPO 22FR 12/30°

Model Number	8622133
Medical Device Problem Codes	Material Fragmentation (1261); Arcing of Electrodes (2289)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf (b)(6) has informed richard wolf gmbh of an issue regarding a cutting electrode bipo 22fr 12/30°, part id: 8622133, lot #21004154.According to the received information, the cutting electrode sparked and broke during a transurethral resection of bladder tumor (turbt) surgery.Because of this, the ceramic tip (part id: 8675322) on the inner shaft broke.The broken part of the ceramic tip was retrieved.There was a reported or time extension of 15 minutes.The scheduled procedure was completed.

• Brand Name: SHARK/S-LINE
• Common Device Name: CUTTING ELECTRODE BIPO 22FR 12/30°
• 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17869654
• Report Number: 9611102-2023-00055
• Device Sequence Number: 17582827
• Product Code: FAS
• UDI-Device Identifier: 04055207018026
• UDI-Public: 04055207018026
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2023

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 Model Number: 8622133
• Device Catalogue Number: 8622133
• Device Lot Number: 21004154
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown