MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. BIOPSY FORCEPS 7FR WL 375MM

Model Number 82907

Device Problem Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

The user facility has informed richard wolf gmbh of an issue regarding a flex.Biopsy forceps 7fr wl 375mm, part id: 829.07, serial number # 4500377830.According to the received information, in (b)(6) 2023, difficulties occurred with the forceps during several operations.During a dj ureteral stent procedure, the pe (biopsy) forceps made it difficult to remove the samples because the instrument did not opened and closed properly.

Manufacturer Narrative

The flex.Biopsy forceps 7fr wl 375mm, part id: 829.07, batch 4500377830 was manufactured on 24/oct/2022.The batch 4500377830 consisted of 43 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.

• Type of Device: FLEX. BIOPSY FORCEPS 7FR WL 375MM
• 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: 17951742
• MDR Text Key: 326043365
• Report Number: 9611102-2023-00060
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 04055207008249
• UDI-Public: 04055207008249
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 82907
• Device Catalogue Number: 829.07
• Device Lot Number: 4500377830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1