BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEEDLE INFOR NOT AVAILABLE

    MDR report key: 1347338 · Received March 19, 2009

    Report

    Report Number
    1347338
    Event Type
    Other
    Date Received
    March 19, 2009
    Date of Event
    January 16, 2009
    Report Date
    March 18, 2009
    Product Code
    GAB
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTRA-OPERATIVELY, GORTEX SUTURE WAS THREADED THROUGH A FREE NEEDLE. SURGEON WAS THROWING A STITCH WHEN THE NEEDLE BROKE OFF IN THE TISSUE. A PORTION OF THE NEEDLE WAS REMOVED AND THE OTHER PORTION OF THE NEEDLE WAS RETAINED. ADDITIONAL SURGEONS ASSISTED IN LOOKING FOR THE RETAINED NEEDLE. AFTER MULTIPLE ATTEMPTS TO FIND THE EXACT LOCATION USING PORTABLE X-RAY AND C-ARM FOR FLUORO, THE THREE DOCTORS COULD NOT FIND THE EXACT LOCATION OF THE NEEDLE. AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE RETAINED NEEDLE, THE THREE DOCTORS DECIDED TOGETHER TO LEAVE THE RETAINED NEEDLE INSIDE THE PT'S ABDOMINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEEDLE INFOR NOT AVAILABLE NONE GAB

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR