MAUDE Adverse Event Report: RICHARD WOLF GMBH SHARK; OUTER SHEATH RESECTOSCOPE 26FR

Model Number	8675426
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The instrument has not yet been sent for examination by the user.A follow-up report will be submitted when device evaluation has been completed.
Event or Problem Description
A user facility has informed richard wolf gmbh an issue regarding an outer sheath resectoscope 26fr sl 189mm, part id: 8675426, lot # unknown.According to the received information, during an endoscopic surgical procedure for a prostatic adenoma, the urethral sheath, part id: 8675426, broke off inside the patient's urethra.There was difficulty in pulling out the urethral sheath and the patient reportedly bled during the process.Additionally, it was determined that the surgical procedure was extended.The procedure includes both devices urethral sheath ref.8675426, and inner sheath ref.8675524.

• Brand Name: SHARK
• Common Device Name: OUTER SHEATH RESECTOSCOPE 26FR
• 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17192620
• Report Number: 9611102-2023-00037
• Device Sequence Number: 12578431
• Product Code: FJL
• UDI-Device Identifier: 04055207019672
• UDI-Public: 04055207019672
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/23/2023

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?: Yes
• Device Model Number: 8675426
• Device Catalogue Number: 8675426
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART ID: 8675524 - INNER SHEATH LASER THERAPY 24FR.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown