MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. 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 (fsca700020652 / notification #: 9611102-03-22-2023-001-c ) 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.

• Brand Name: NA
• Type of Device: FLEX. GRASP. FORCEPS 6.6FR WL 550MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• MDR Report Key: 17010181
• MDR Text Key: 316018749
• Report Number: 1418479-2023-00013
• Device Sequence Number: 1
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/26/2023

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: 4500352416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2023
• Distributor Facility Aware Date: 05/10/2023
• Device Age: 13 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/26/2023
• Patient Sequence Number: 1