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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned to manufacturer.However, device evaluation has not yet begun.
Event or Problem Description
The manufacturer richard wolf gmbh has issued an advisory notice (fsca700020652 / notification #: (b)(4) ) regarding flex.Grasp.Forceps not functioning properly.The users are having difficulty in opening and closing the graspers.The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue regarding a flex.Grasp.Forceps 5fr wl 550mm, part id: 828.051, batch # 4500353558.The complainant called about the forceps notification and checked the devices they had.She found that 828.051 device had trouble opening.The device jaw will not open slowly/smoothly when at an angle.She described it as "feeling the forceps catch".The complainant stated that the device was not being used for a procedure.It was checked only because of the fsca700020652 notice.Rwgmbh has verified that part id: 828.051, batch # 4500353558 is affected by the fsca700020652 notice.Therefore, an mdr report is being submitted.

• 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: 17121116
• Report Number: 1418479-2023-00015
• Device Sequence Number: 6611823
• Product Code: GEN
• UDI-Device Identifier: 04055207009574
• UDI-Public: 04055207009574
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/13/2023
• Report Date (Section F): 06/13/2023

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: 828051
• Device Catalogue Number: 828.051
• Device Lot Number: 4500353558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/17/2023
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2023
• 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: 06/13/2023