BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3002417 · Received March 8, 2013

    Report

    Report Number
    2134070-2013-00046
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K012578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION, IT WAS FOUND THAT THE STOPCOCK LEVER WAS LOOSE AND DID NOT HAVE SUFFICIENT FRICTION TO PREVENT UNINTENDED MOVEMENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. AS EACH DEVICE IS VISUALLY AND FUNCTIONALLY TESTED PRIOR TO RELEASE, NO CONCLUSION COULD BE DRAWN AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEVER REGULATING THE GAS WAS LOOSE AND OPENED ON IT OWN DURING SURGERY, RESULTING IN A LOSS OF CO2. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THE PROCEDURE WAS EITHER A VIDEO LAPAROSCOPIC CHOLECYSTECTOMY OR VIDEO LAPAROSCOPIC APPENDECTOMY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99581 NA NLM STERILMED, INC. AUT179095P

    Patients

    Seq Age Sex Outcome Treatment
    1