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 2 devices of flex.Grasp.Forceps 5fr wl 550mm, part no.828.051, batch # 4500359201.The user facility stated on the 1st device, "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." rwmic assigned complaint # (b)(4) on 1st device.This was reported under importer mdr 1418479-2023-00006 and manufacturer mdr 9611102-2023-00015.A 2nd device was returned together with the 1st device.Richard wolf medical instruments corp.(rwmic) assigned complaint # (b)(4).The user facility shipped back this device since, both devices have similar product id: 858.051 and belongs to the same batch # 4500359201.Only the 1st device was involved in the reported incident.On 26/apr/2023, a preliminary device evaluation was performed with the 2nd device (b)(4) at richard wolf medical instruments corp.(rwmic).According to the responsible service department, the reported condition was confirmed that the jaws do not close consistently.However, physical cause of the issue could not be determined.Rwmic decided to report as the 2nd device exhibits a similar issue.Also, there was notification #: (b)(4) assigned on this matter.Further investigation is on-going.

• 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
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: marco bruxmeier ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17002261
• Report Number: 9611102-2023-00030
• Device Sequence Number: 15026811
• Product Code: GEN
• UDI-Device Identifier: 04055207009574
• UDI-Public: 04055207009574
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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: 4500359201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9611102-03-22-2023-001-C
• Patient Sequence Number: 1
• Patient Sex: Unknown