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 Date 05/05/2023

Event Type  malfunction  

Event Description

The user facility has informed richard wolf medical instruments corporation (rwmic) of an issue regarding a flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, batch # 4500098494.According to the received information, the instrument does not open properly.The device issue was discovered prior to use and device was not being used on a patient when the reported issue was identified.There was no risk to the patient or personnel reported.

• 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: 17051482
• MDR Text Key: 316434287
• Report Number: 9611102-2023-00033
• 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,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• 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: 4500098494
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1