BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OWENS & MINOR

    MDR report key: 2492912 · Received February 10, 2012

    Report

    Report Number
    MW5024616
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 10, 2012
    Manufacturer
    OWENS & MINOR DC 74
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TAKEN FROM THE SURGEON'S REPORT: "FOR THIS REASON IT WAS ELECTED TO DIVIDE THE CYSTIC DUCT USING AN ENDO-GIA STAPLING DEVICE. IT WAS DEEMED FAR TOO LARGE FOR NORMAL SURGICAL CLIPS. THE GALLSTONES IMPACTED IN THE CYSTIC DUCT WERE THEN MILKED DISTALLY INTO THE FUNDUS OF THE GALLBLADDER. A 30-MM ENDO-GIA WAS THEN PLACED OVER THE CYSTIC DUCT AND FIRED. IT MISFIRED AND MANY MISSHAPEN STAPLES WERE LEFT IN PLACE, BUT THE LUMEN WAS CLEARLY LEFT OPEN. IT WAS UNCLEAR WHETHER IT MISFIRED BECAUSE OF A TECHNICAL PROBLEM WITH THE STAPLER ITSELF OR WHETHER A RETAINED STONE IN THAT AREA HAD INTERFERED WITH THE MECHANISM. NONETHELESS, WE WERE LEFT WITH A LARGE, OPEN, MASSIVELY DILATED AND INFLAMED CYSTIC DUCT. FOR THIS REASON IT WAS ELECTED TO OVERSEW THE END OF THE DUCT WITH A PDS SUTURE. A 4-0 PDS SUTURE WAS THEN USED TO SEW THE OPEN END OF THE BILE DUCT CLOSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OWENS & MINOR ENDO GIA GDW OWENS & MINOR DC 74 030450 ENDO GIA UNIV N9B113

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR