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
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.
Additional Manufacturer Narrative
The following fields have new information: h6 (type of investigation, investigation findings, and investigation conclusions).The flex.Grasp.Forceps 5fr wl 550mm 828.051, batch#: 4500353558 was investigated by rwmic responsible department.The flexible biopsy forceps has been tested in the forceps function test fixture and in accordance with prtcl 23-0009.After reprocessing at the rwmic facility, the device did not function as intended when used in the test apparatus at 0 degree.It was difficult to open the jaws smoothly.After adding instrument oil, the device functioned as intended in the test fixture at the full range of test angles (0, 90, and 180 degree).The device was reprocessed again to see if the reprocessing had any effect on the function.After reprocessing, the device was tested and demonstrated full functionality.A reprocessing error was determined to be the probable root cause of the issue.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 ifu recommends the forceps to be oiled particularly in section 10.1: "after machine/manual disinfection: lightly oil the jaw section at the joint using 1-2 drops of instrument oil.Apply 2-3 drops of oil to the cleaning connection and open and close the jaw section.".

• 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: 17121147
• Report Number: 9611102-2023-00035
• Device Sequence Number: 12405689
• Product Code: GEN
• UDI-Device Identifier: 04055207009574
• UDI-Public: 04055207009574
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2022
• 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
• 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