MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK/S-LINE; BIVAP ELECTRODE BIPO 24-26FR 12/30°

Model Number	46300243
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	10/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite repeated requests, richard wolf gmbh have not yet received any additional information from the customer whether the broken piece of the electrode remained in the patient's uterus.Device is not yet returned to manufacturer for investigation.
Event or Problem Description
It was reported that "the resection loop broke during the operation.A piece appears to have remained in the patient's uterus.".

• Brand Name: SHARK/S-LINE
• Common Device Name: BIVAP ELECTRODE BIPO 24-26FR 12/30°
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20738104
• Report Number: 9611102-2024-00038
• Device Sequence Number: 18233381
• Product Code: FAS
• UDI-Device Identifier: 04055207048948
• UDI-Public: 04055207048948
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 46300243
• Device Catalogue Number: 46300243
• Device Lot Number: 21005292
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown