BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTRE

    MDR report key: 3770291 · Received January 6, 2014

    Report

    Report Number
    2134070-2014-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2014
    Date of Event
    December 12, 2013
    Report Date
    December 17, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K043592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE GASKET SEPARATE FROM THE SLEEVE OF THE DEVICE. THERE WERE NO CUTS OR TEARS ON THE GASKET. THE OBTURATOR WAS RETURNED IN GOOD VISUAL CONDITION. UPON EVALUATION, THE GASKET WAS ASSEMBLED BACK ONTO THE SLEEVE AND THE SLEEVE WAS PRESSURE TESTED. THE SLEEVE SHOWED SIGNS OF LEAKING WHEN THE OBTURATOR WAS INSERTED. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FELL APART UPON INSERTION, LEAKING GAS, TOOK TOP OFF - GASKET (RING) FELL OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8331 AUTO SUTRE ENDOSCOPIC TROCAR NLM STERILMED, INC. AUTNB12STF 1681554

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR