BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE

    MDR report key: 3022819 · Received March 21, 2013

    Report

    Report Number
    MW5029489
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    TYCO/HEALTHCARE/UNITED STATES SURGICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) /2013, DURING A LAPAROSCOPIC REDUCTION AND REPAIR OF BILATERAL INGUINAL HERNIAS A DISSECTING BALLOON WAS BLOWN UP UNDER VISION VIA THE CAMERA IN THE PROPERITONEAL SPACE. WHEN THE TROCAR WAS REMOVED, THE BALLOON AND SHEATH DISCONNECTED FROM THE DEVICE AND REMAINED WITHIN THE PROPERITONEAL SPACE. THIS WAS IMMEDIATELY RECOGNIZED AND BOTH THE DISSECTING BALLOON AND ITS SHEATH WERE SUCCESSFULLY RETRIEVED FROM THE PT. THERE IS SIGNIFICANT POTENTIAL FOR A RETAINED FOREIGN BODY WITH THIS TYPE OF EQUIPMENT MALFUNCTION. THE LOT # PROVIDED IS FROM A NEW PACKAGE AS THE ORIGINAL PACKAGE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117944 AUTO SUTURE OVAL-PREPERITONEAL DISTENTION BALLOON AND INFLATION GCJ TYCO/HEALTHCARE/UNITED STATES SURGICAL OMS-PDBS2 P2L0046

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other HYDRAMINE| MORPHINE| MUPIROCIN| MENTHOL/CAMPHOR FOR RASH| PROMETHAZINE| LORAZEPAM| FEXOFENADINE| THYMOGLOBULIN| RANITIDINE| HYDROXYZINE| LEVOFLOXACIN