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

Model Number	8622133
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the present time, with the current information available to us, we consider the case to be closed.If new information comes in, the case will be reassessed and a follow-up report will be submitted.
Event or Problem Description
Richard wolf gmbh has been informed of an issue regarding a cutting electrode bipo 22fr 12/30°, part id: 8622133, batch# 21004873.According to the received information, during a hysteroscopy resection, the electrode was burnt through one side at the end of the arch.The hospital reported that there was no loud sound, just the light was brighter than usual.The surgeon searched for a fragment of the loop tip for about 30 minutes just in case, but no fragment was found.The user reported the operation was completed with a replacement and there was no patient injury as a result of the incident.

• Brand Name: SHARK/S.-LINE
• Common Device Name: CUTTING ELECTRODE BIPO 22FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• 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: 20138978
• Report Number: 9611102-2024-00028
• Device Sequence Number: 15303392
• Product Code: FAS
• UDI-Device Identifier: 04055207018026
• UDI-Public: 04055207018026
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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: Health Professional
• Device Model Number: 8622133
• Device Catalogue Number: 8622133
• Device Lot Number: 21004873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2023
• 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