MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEFLEX. 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.
Additional Manufacturer Narrative
The following fields have new information: h6 (type of investigation, investigation findings, and investigation conclusions).The flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, batch#: 4500352416, was investigated in the responsible department.The investigations revealed that the damaged was beyond the ability to be tested per prtcl 23-0009.The instrument was not able to fit properly in test fixture.Further investigations showed a severe damage to the pull rod and flexible metal tube.These parts were completely locked together.Finally, twelve separate points of damage to pull rod and/or outer tube was found.In this case, improper handling is indicated as damage found to be consistent with significant abuse over a prolonged period.Due to it, the instrument was scrapped.The reported flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685 is from batch: 4500352416 and it was produced on 20/apr/2022.The batch contains 14 pieces.No anomalies were detected during production.Rw gmbh has a total of 13 similar complaints "jaws will not open" including the current one regarding flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685 received during the review period from 01/01/2019 to 10/20/2022.In general, the user is advised in the associated instructions for use ga-s004/ en/ us /v3.0 / 2021-11 / pk21-0310 under chapter 8 that a visual and functional check must be carried out before and after each use.Possible functional impairments of the above type can be easily detected by the user if these instructions are followed.In our risk analysis b1-2 rev.05, manufacturing-related, handling-related and design-related hazards, with regard to a functional impairment, as well as risks due to a product that cannot be used, with the corresponding extent of damage and the assumed probability of occurrence, and assessed with an acceptable risk.

• Brand Name: NA
• Common Device Name: FLEFLEX. 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: marco bruxmeier ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17010073
• Report Number: 9611102-2023-00031
• Device Sequence Number: 7500661
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/27/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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