BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPIO SUTURE CAPTURING DEVICE

    MDR report key: 1328544 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-01884
    Event Type
    Injury
    Date Received
    March 3, 2009
    Date of Event
    April 25, 2005
    Report Date
    May 26, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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 WILL NOT 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 DURING A PROCEDURE USING A CAPIO SUTURE CAPTURING DEVICE, THE PHYSICIAN NOTED THAT THE NEEDLE WAS MISSING FROM THE CAPIO AFTER IT WAS FIRED. AN X-RAY CONFIRMED THE NEEDLE WAS INSIDE THE PATIENT. THE NEEDLE WAS NOT ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE CAPTURING DEVICE HOLDER, NEEDLE, GASTROENTEROLOGIC FHQ BOSTON SCIENTIFIC CORPORATION-MIAMI M0060000120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other