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

Model Number 8680204

Device Problem Material Separation (1562)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 10/03/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 326500051
• Report Number: 9611102-2023-00062
• Device Sequence Number: 1
• Product Code: FDC
• UDI-Device Identifier: 04055207042922
• UDI-Public: 04055207042922
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K062720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8680204
• Device Catalogue Number: 8680.204
• Device Lot Number: 1476165
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other