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 24/feb/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
• MDR Report Key: 16506372
• Report Number: 1418479-2023-00006
• Device Sequence Number: 3353878
• Product Code: GEN
• UDI-Device Identifier: 04055207009574
• UDI-Public: 04055207009574
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2023
• Report Date (Section F): 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2023
• Device Age: 8 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/08/2023