MAUDE Adverse Event Report: Richard Wolf GmbH SHARK; INTERNAL SHEATH RESECTOSCOPE 24FR

Model Number	8675324
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 24FR
• 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: 50794812
• Report Number: 9611102-2026-00060
• Device Sequence Number: 10510472
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K062720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1600347
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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