MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEFLEX. GRASP. FORCEPS 6.6FR WL 550MM

Model Number 8736685

Device Problem Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The following fields have new information: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, and investigation conclusions), and h10.Corrections: d4 (lot #), h4 (device manufacture date).The flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, batch # 4500291342, was investigated at rwmic.The investigations revealed that the pull-rod was severed behind distal grasper.Further investigations showed the distal end of flexible metal tube was stretched.Damage was likely caused concurrently to pull-rod damage due to exactly matched position.The most common cause of a combination of a stretched flexible tube and broken pull rod is an attempt to withdraw the instrument through a working channel while holding an item too large to fit through the channel.Therefore, user error has been determined to be the root cause.The reported flex.Grasp.Forceps 6.6fr wl 550mm.Part id: 8736.685 was from batch 4500291342 and it was produced on (b)(6) 2020.The batch contains 15 pieces.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 (b)(6) 2019 to (b)(6) 2022.In general, the user is advised in the associated instructions for use ga-s004/ en/ us /v3.0 / (b)(6) 2021 / (b)(4) 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.The subject issue of device graspers not functioning is present in the risk management file 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.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
• Type of Device: 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: 17010243
• MDR Text Key: 316885506
• Report Number: 9611102-2023-00032
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2023
• 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: 4500291342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: 9611102-03-22-2023-001-C
• Patient Sequence Number: 1