BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE PLACEMENT SYSTEM

    MDR report key: 2003214 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00543
    Event Type
    Injury
    Date Received
    February 28, 2011
    Report Date
    February 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K973415
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNKNOWN; CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED. (B)(4) - NEEDLE DETACHMENT. THE ROOT CAUSE FOR THIS EVENT IS CONSIDERED UNDETERMINABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE "DEVICE FAILED DURING SURGERY." REPORTEDLY, THE NEEDLE WAS "LEFT IN THE PATIENT." THE SUTURE TYPE AND MANUFACTURER ARE UNKNOWN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI M0068311350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other