MAUDE Adverse Event Report: AVALIGN GERMAN SPECIALTY INSTRUMENTS V. MUELLER; MIS DEBAKEY FORCEPS

Catalog Number CH5916-3

Device Problem Mechanical Jam (2983)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 08/21/2019

Event Type  malfunction  

Event Description

Ch5916-3 mis debakey forcep str - would stick shut during case, would not release when loosening pressure on handle.After cleaning/sonicing they still do not release well.Have to manually pull jaws apart.The surgeon stated that he felt the patient did not do as well due to the problems that occurred with the instrumentation.The scheduled procedure was to repair the valve.The repair did not hold, so tried to rework the ring, and ended up replacing the valve.The surgeon struggle with the opening and closing of instruments the entire case.This resulted in the patient being under anesthesia for a prolonged period of time and possibly an unnecessary procedure.

• Brand Name: V. MUELLER
• Type of Device: MIS DEBAKEY FORCEPS
• Manufacturer (Section D): AVALIGN GERMAN SPECIALTY INSTRUMENTS; 626 cooper ct; schaumburg IL 60173
• Manufacturer (Section G): AVALIGN GERMAN SPECIALTY INSTRUMENTS; unter buchsteig 3; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: jennifer staunton ; 626 cooper ct; schaumburg, IL 60173 ; 8479080292
• MDR Report Key: 9406540
• MDR Text Key: 179226085
• Report Number: 1421101-2019-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403180972
• UDI-Public: 10885403180972
• Combination Product (y/n): N
• PMA/PMN Number: K040855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CH5916-3
• Device Lot Number: XFAZ11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1