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)
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer richard wolf gmbh has issued an advisory notice ((b)(4) / notification #: (b)(4) ) regarding flex.Grasp.Forceps not functioning properly.The users are having difficulty in opening and closing the graspers.In response to the notice, the customer stated they have 2 forceps that were out of use.The suspect device is flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, batch # 4500352416.

• 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: 17009987
• Report Number: 1418479-2023-00012
• Device Sequence Number: 17860674
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/26/2023
• Report Date (Section F): 05/26/2023

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: 4500352416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 13 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/26/2023