MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. GRASP. FORCEPS 5FR WL 550MM

Model Number	828051
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional reported an issue regarding flex.Grasp.Forceps 5fr wl 550mm, part no.828.051, batch# 4500359201.The user reports "when opening and closing the grasper it feels like there is a pinch in the shaft of the grasper and it is visible when look at the tips open and close.During a cystoscopy stent removal procedure, the doctor was unable to grab the stent due to the faulty equipment.Additional information was received from the user facility representative on (b)(6) 2023.According to the received information, there was a delay of 15 minutes in the procedure which put the patient at risk.However, the procedure was successfully completed with a back-up device.

• Brand Name: NA
• Common Device Name: FLEX. GRASP. FORCEPS 5FR 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: zsófia bartholome-nagy ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16506441
• Report Number: 9611102-2023-00015
• Device Sequence Number: 3290749
• Product Code: GEN
• UDI-Device Identifier: 04055207009574
• UDI-Public: 04055207009574
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 828051
• Device Catalogue Number: 828.051
• Device Lot Number: 4500359201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown