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	Insufficient Information (4580)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has informed richard wolf gmbh of an issue regarding a flex.Grasp.Forceps 7fr wl 365mm, part id: 828.07, serial number # (b)(6).According to the received information, in (b)(6) 2023, difficulties occurred with the forceps during several operations.With the grasping forceps, a double-j stent could not be grasped and removed, as they could not be opened/closed properly, thus no grasping was possible.
Additional Manufacturer Narrative
The flex.Grasp.Forceps 7fr wl 365mm, part id: 828.07, batch 4500381590 was manufactured on 13/dec/2022.The batch consisted of 100 pieces.The examination of the customer's forceps has shown that the instructions for use (ga-s004 / en / us /v3.0 / 2021-11 / pk21-0310 (rw: en / eu / v3.0 / 2021-11/ pk21-0310) regarding instrument reprocessing has not been fully followed.In chapter 10.1 reprocessing procedure - flexible forceps, the following is described under inspection and maintenance on page 21: "care 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.Ensure that all other surfaces are free of oil.Wipe away any excess oil." the jaw sections could be moved without any defects after oiling.The defect could have been detected early according to chapter 8 checks."injury due to damaged or incomplete products! injuries of the patient, user and others are possible.Run through the checks before and after each use.Do not use the products if they are damaged, incomplete or have loose parts.Do not attempt to do any repairs yourself." in chapter 8.2 function checks, the function is explicitly checked "check that the jaw sections open and close properly." in summary, a user error can be assumed.The incident could have been avoided if the information in the operating instructions has been observed.

• Common Device Name: FLEX. GRASP. FORCEPS 7FR WL 365MM
• 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: oliver ehrlich ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 17950946
• Report Number: 9611102-2023-00059
• Device Sequence Number: 20715551
• Product Code: FCL
• UDI-Device Identifier: 04055207008195
• UDI-Public: 04055207008195
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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: 4500381590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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
• Patient Sex: Unknown