MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. GRASP. FORCEPS 6.6FR WL 550MM

Model Number 8736685

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 11/20/2023

Event Type  Injury  

Manufacturer Narrative

Flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, was produced on march 22, 2021 with the lot number 4500330894.The batch size was 13 units.There have been 2 complaints related to this batch number with a similar issue since then and including this case.The user facility stated that the instrument with this lot number has been utilized approximately 20 splint removals in the past 2 years and 3 months.

Event Description

The user facility has informed richard wolf gmbh (rwgmbh) of an issue regarding an flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, lot # 4500330894.According to the received information, a procedure to remove the ureteral stent was planned using the surgical instrument."after insertion into the working channel, the forceps were opened to grip the splint.When gripping/closing, the jaws blocked.Forceps did not close.After actuating the gripping device several times, the forceps finally closed.We removed the forceps and aborted the procedure to prevent it from blocking again.The instrument was checked for integrity before sterilization.Also immediately before use on the patient.It then failed during the procedure." there is no report of injury to the patient or other personnel.However, the reported issue caused a 10 minute delay and the scheduled procedure was not completed.

• Type of Device: FLEX. GRASP. FORCEPS 6.6FR WL 550MM
• 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: 18364762
• MDR Text Key: 330999442
• Report Number: 9611102-2023-00074
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8736685
• Device Catalogue Number: 8736.685
• Device Lot Number: 4500330894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2021
• 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
• Patient Outcome(s): Other