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
Additional Manufacturer Narrative
Flex.Grasp.Forceps 6.6fr wl 550mm, 8736.685, batch # 4500338558 was investigated by the responsible department in accordance with the test procedure tp-399 rev 00.During the evaluation of the device, it was determined that the grasper forceps were jammed and not functioning at all.Debris were found in the jaw joint during the preliminary cleaning.Further, it seemed that the accumulated particles have not been removed during normal cleaning.The root cause of the failure clearly indicates that the device was not properly and adequately cleaned during reprocessing.Flex.Grasp.Forceps 6.6fr wl 550mm, 8736.685, batch # 4500338558 was manufactured on 07/oct/2021.The batch consisted of 8 pieces.Only one (1) piece was delivered to this customer.In the relevant ifu ga-s004 / en / us / v3.0 / 2021-11 / pk21-0310 contains several reprocessing and maintenance notes regarding the cleaning process in section 10.The user is also advice to follow visual and function checks in sections 8.1 and 8.2.The subject issue of unusable device is present in the risk management file b 1-2: reusable non-optical graspers and scissors, rev.: r05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.
Event or Problem Description
The user facility has informed richard wolf medical intruments 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
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 16955902
• Report Number: 9611102-2023-00025
• Device Sequence Number: 17855140
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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