BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1328550 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-01881
    Event Type
    Injury
    Date Received
    March 3, 2009
    Report Date
    November 30, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE IS LOST AND CANNOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT FOLLOWING A SACROSPINUS LIGAMENT FIXATION PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THERE WAS A NEEDLE UNACCOUNTED FOR IN THE FINAL COUNT. IT IS UNKNOWN IF THE MISSING NEEDLE WAS LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION-MIAMI M0068311251

    Patients

    Seq Age Sex Outcome Treatment
    1 Other