BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2950519 · Received February 5, 2013

    Report

    Report Number
    2134070-2013-00024
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K052299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH THE SEAL CAP BROKEN ALONG THE WELD SEAM AND NO LONGER INTACT. THE OBTURATOR WAS NOT RETURNED. NO PACKAGING WAS RETURNED WITH THE DEVICE TO DETERMINE MANUFACTURING OR EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE DEVICE WAS PLACED IN THE PT AND "HELD" UNTIL THE SCOPE WAS PULLED OUT. AT THAT TIME THE CAP POPPED OFF AND INSUFFLATION WAS LOST. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48487 NA NLM STERILMED, INC. ETHB11LT

    Patients

    Seq Age Sex Outcome Treatment
    1