BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2982734 · Received February 25, 2013

    Report

    Report Number
    2134070-2013-00038
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THERE WAS A CRACK LINE ON THE INSIDE OF THE HOUSING COMPONENT. UPON EVALUATION, THE DEVICE WAS FUNCTION TESTED TO DETECT ANY LEAKING ISSUES. THE DEVICE SHOWED NO SIGNS OF LEAKING WHEN TESTED BY ITSELF. A TEST OBTURATOR THEN WAS INSERTED INTO THE DEVICE, AND THE DEVICE WAS NOTED TO LEAK. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE THE DEVICE LEAKED DURING SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS RECEIVED. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79406 NA NLM STERILMED, INC. APPCTS02

    Patients

    Seq Age Sex Outcome Treatment
    1