MAUDE Adverse Event Report: RICHARD WOLF GMBH S-LINE; WORKING ELEMENT ACTIVE BIPO 0/12/30°

Model Number	8680204
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding a working element active bipo 0/12/30°, part id: 8680.204, lot # 1476165.According to the received information, the device was broken proximally during a transurethral resection of the prostate (turp), during which a part of the prostate diseased tissue was resected, from prostate.It happened during the resection of the tissue.The patient has moderate bleeding, which is improved by traction with a folley catheter.Due to the break of the instrument, the operation time has been prolonged by one(1) hour.Now the patient is doing well.A replacement device was used to complete the scheduled surgery.

• Brand Name: S-LINE
• Common Device Name: WORKING ELEMENT ACTIVE BIPO 0/12/30°
• 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: 18004395
• Report Number: 9611102-2023-00062
• Device Sequence Number: 20752579
• Product Code: FDC
• UDI-Device Identifier: 04055207042922
• UDI-Public: 04055207042922
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8680204
• Device Catalogue Number: 8680.204
• Device Lot Number: 1476165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown