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

Model Number	8736685
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported an issue regarding flexible grasper forceps 6.6fr wl 550mm, part no.8736.685, batch 4500367417.The user reports "forceps not functioning properly.Will not open and close when inside of scope.If you deflect the scope it will not work." additional information was received from the user facility representative on january 31, 2023.According to the received information, there was a delay of 5 minutes while resolving the issue and retrieved a back-up device to complete the procedure.There was no harm or risk to the patient.

• Brand Name: NA
• Common Device Name: FLEX. GRASP. FORCEPS 6.6FR WL 550MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 16461893
• Report Number: 1418479-2023-00005
• Device Sequence Number: 17782243
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2023
• Report Date (Section F): 03/01/2023

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: 8736685
• Device Catalogue Number: 8736.685
• Device Lot Number: 4500367417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2023
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/01/2023