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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Richard wolf medical instruments corporation (rwmic) received a medwatch report, mw5158447, regarding an issue with an internal sheath resectoscope 24fr, part id: 8675324, batch# 1562220.According to the received information, "during the procedure, the doctor identified the ceramic tip had broken off and was in the bladder.The broken item was removed and the or manager was notified.The doctor viewed the removed ceramic tip with the original part and determined it was complete.No evidence of any other foreign object was identified.The bladder was irrigated and drained prior to the completion of the case." later information obtained, that the reported issue caused a 5-10 minutes delay during the procedure while the surgeon retrieved the broken piece.However, no apparent harm occured in relation to the adverse event.

• Brand Name: SHARK
• Common Device Name: INTERNAL SHEATH RESECTOSCOPE 24FR
• 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: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 20270725
• Report Number: 9611102-2024-00030
• Device Sequence Number: 7419459
• Product Code: FJL
• UDI-Device Identifier: 04055207019658
• UDI-Public: 04055207019658
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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: 8675324
• Device Catalogue Number: 8675324
• Device Lot Number: 1562220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White