BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3042947 · Received April 4, 2013

    Report

    Report Number
    2134070-2013-00080
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NLM
    PMA / PMN Number
    K111002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE INVESTIGATION FOUND THAT THE DEVICE WAS RETURNED WITH A PIECE OF THE BLACK RUBBER PLEATED SHIELD INSIDE THE DUCK BILL AREA BUT DISLODGED. THE OBTURATOR WAS NOT RETURNED. NO PACKAGING AND RETURNED WITH THE DEVICE SO THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO BEING RELEASED, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY WHEN THE SURGEON ATTEMPTED TO PUT A LAPAROSCOPIC INSTRUMENT THROUGH THE DEVICE, A PIECE OF RUBBER DISLODGED AND WAS LOST "FOR SOME TIME." THE PIECE WAS FOUND IN THE PT'S ABDOMEN AND WAS REMOVED WITHIN "SECONDS." ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138727 NA NLM STERILMED, INC. APPC0R37

    Patients

    Seq Age Sex Outcome Treatment
    1