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

Model Number 8675426

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 06/06/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 318070269
• Report Number: 9611102-2023-00037
• Device Sequence Number: 1
• Product Code: FJL
• UDI-Device Identifier: 04055207019672
• UDI-Public: 04055207019672
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PART ID: 8675524 - INNER SHEATH LASER THERAPY 24FR.
• Patient Outcome(s): Other