BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3881012 · Received April 9, 2014

    Report

    Report Number
    2134070-2014-00067
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. THE SHAFT WAS NOT VISIBLY BENT. THE JAW APPEARED TO BE IN ALIGNMENT. THE CLIP RETAINER, PUSH FORK AND JAW CLEARANCE WERE ACCEPTABLE. UPON EVALUATION, THE 10 REMAINING CLIPS WERE CYCLED, FED AND PRODUCED WITH PROPER PINCH AND ALIGNMENT. AFTER THE LAST CLIP WAS FIRED, THE LOCKING MECHANISM ENGAGED AS INTENDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS THE DEVICE OPERATED AS INTENDED DURING EVALUATION, NO CONCLUSION COULD BE MADE AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS WERE NOT FIRING AND CROSSING AT THE TIPS. THERE WAS A 5-10 MINUTE DELAY FOR TROUBLESHOOTING AND RETRIEVING ANOTHER DEVICE. THERE WAS NO CHANGE IN PATIENT STATUS DURING THAT TIME, AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213127 NA NMJ NMJ STERILMED, INC. ETHER320 1734127

    Patients

    Seq Age Sex Outcome Treatment
    1