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	09/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue regarding a flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, batch # 4500338558.The part number and batch of the reported device is involved in the richard wolf notification fsca700020652 / 9611102-03-22-2023-001-c.In response to the notification, the customer identified 'this piece does not open at all'.Grasper not opening properly prior to the procedure.According to the received information, the device was not being used on a patient when the reported issue was identified.The device issue was discovered prior to use and no risk to patient or personnel was reported.

• 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: 16955669
• Report Number: 1418479-2023-00007
• Device Sequence Number: 7041144
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Type of Report: Initial
• Report Date (Section B): 05/18/2023
• Report Date (Section F): 05/18/2023

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
• Device Model Number: 8736685
• Device Catalogue Number: 8736.685
• Device Lot Number: 4500338558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2023
• Device Age: 19 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/18/2023