BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3915371 · Received May 28, 2014

    Report

    Report Number
    2134070-2014-00107
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    April 22, 2014
    Manufacturer
    STERILMED, INC.
    Product Code
    NUJ
    PMA / PMN Number
    K120040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE JAW MISALIGNED AND JAMMED CLOSED. THE BLADE WAS EXTENDED WITHIN THE JAWS, BUT FULLY CONTAINED. UPON EVALUATION THE JAW WAS UNABLE TO BE OPENED. THE BLADE TRIGGER WAS STUCK CAUSING THE HANDLE NOT TO OPERATE PROPERLY. THE DISTANCE BETWEEN THE JAWS WAS 2.29MM. NO ELECTRICAL TESTING WAS PERFORMED DUE TO THE CONDITION OF THE RETURNED DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED. THE INSTRUCTIONS FOR USE STATE "DO NOT OVERFILL THE JAWS OF THE INSTRUMENT WITH TISSUE. THIS MAY DAMAGE THE CUTTING MECHANISM OR CAUSE THE BLADE TO DEPLOY OUTSIDE OF ITS GUIDING FEATURES, POSSIBLE RESULTING IN DIFFICULTY OPENING THE JAWS OR UNINTENDED INJURY TO THE USER OR PATIENT" AND "CARE SHOULD BE TAKEN TO VERIFY THE JAWS ARE FULLY CLOSED (LESS THAN 2MM...) PRIOR TO ENGAGING THE CUTTING BLADE AS THIS MAY DAMAGE THE DEVICE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT WORK. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DEVICE WAS LOCKED ON FATTY TISSUE BUT ABLE TO BE REMOVED AFTER THE TISSUE WAS CAUTERIZED WITHOUT INJURY TO THE PATIENT. THE CARE WAS NOT MODIFIED, BUT ANOTHER DEVICE WAS USED FOR THE COMPLETION OF THE CASE. THE DEVICE HAD BEEN TESTED PRIOR TO USE AND SOME SUCCESSFUL CUTS HAD BEEN MADE PRIOR TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314557 NA NUJ STERILMED, INC. COVLF4200 1752323

    Patients

    Seq Age Sex Outcome Treatment
    1