MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. GRASP. FORCEPS 7FR WL 365MM

Model Number	82807
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The flex.Grasp.Forceps 7fr wl 365mm, part no.82807, was manufactured on (b)(6) 2022.No further complaints are known from the batch # (b)(4).As soon as the investigations are completed, a follow-up report will be submitted.
Event or Problem Description
The physician reported that during a cystoscopy, he has inserted the flex.Grasp.Forceps 7fr wl 365mm, part no.82807, via working channel, but the grasper could not be opened.The physician retrieved the grasper and the working channel from patient.The grasper still would not open outside the patient.According to the user, there was no injury to the patient.However, the scheduled procedure was not completed.A follow-up procedure was performed successfully on the following day with an exchange device.
Additional Manufacturer Narrative
The flex.Grasp.Forceps 7fr wl 365mm 82807 was investigated in the responsible department.The visual and functional investigations revealed that the outer spiral is kinked proximally at the transition to the reinforcing tube.If the forceps is bent in the distal area, hacking / cracking was noticeable.However, it was possible to open the jaws any time.The jaws opened normally up to a total bend of 270° which meets the requirement for use with rigid sheath.After disassembling the jaws, the distal tie rod area was found to be straight and the jaws moved smoothly.The hacking/cracking from functional test cannot be reproduced at this point.The cause of the fault described by the user cannot be confirmed, the function of the jaws is operational despite the kink and the hacking.The flex grasp.Forceps 7fr wl 365mm 82807, batch # 4500374644 was produced on 12/01/2022.No issues were identified during production.The ifu ga-s004 / en / us / v3.0 / 2021-11 / pk21-0310 contains several description of visual and functional checks which serve to detect fault prior to use on patient in section 8 checks.Furthermore, the user is informed about the limited strength of the device in section 9 use.The subject issue of device failure is present in the risk management file b1-3: reusable non-optical graspers and scissors, rev.05.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: NA
• Common Device Name: FLEX. GRASP. FORCEPS 7FR WL 365MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 2; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: zsófia bartholome-nagy ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16366911
• Report Number: 9611102-2023-00008
• Device Sequence Number: 20718722
• Product Code: FCL
• UDI-Device Identifier: 04055207008195
• UDI-Public: 04055207008195
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K971315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 82807
• Device Catalogue Number: 828.07
• Device Lot Number: 4500374644
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown