BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2971712 · Received January 30, 2013

    Report

    Report Number
    2134070-2013-00020
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION WITH NO CRACKS OR GAPS THAT WOULD INDICATE A LEAK. UPON EVALUATION, THE DEVICE WAS TESTED FOR LEAKING. THE DEVICE PASSED THE LEAK TEST WHEN TESTED BY ITSELF, BUT WAS FOUND TO SHOW EVIDENCE OF MINOR LEAKING WHEN A TEST OBTURATOR WAS INSERTED INTO THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR THE DEVICE LEAKED GAS WHEN AN INSTRUMENT WAS INSERTED THOUGH IT. IT WAS UNCLEAR FROM WHERE THE LEAKING ORIGINATED. THE ABDOMEN DEFLATED. A FEW MINUTES WERE TAKEN TO INSERT AND REINSERT THE SCOPE AND/OR OTHER DEVICES INTO THE DEVICE TO CONFIRM THE LEAKING. THEN ANOTHER COUPLE OF MINUTES WERE TAKEN TO REMOVE AND REPLACE THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41896 NA NLM STERILMED, INC. APPCTS02

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR