BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2111096 · Received June 2, 2011

    Report

    Report Number
    3005099803-2011-01862
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    March 18, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SUTURE CAPTURING DEVICE (TYPE UNKNOWN) WAS USED WITH A POLYPROPYLENE 48-INCH SIZE 0 CAPIO SUTURE DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE. ACCORDING TO THE COMPLAINANT, THE NEEDLE OF THE SUTURE DETACHED INSIDE THE PATIENT DURING THE PROCEDURE. THE BREAK WAS RIGHT AT THE NEEDLE. THREE SUTURES WERE PLACED THROUGH THE ARCUS TENDINEUS ON THE PATIENT'S RIGHT AND LEFT SIDE. THE NEEDLE THAT DETACHED WAS FROM THE MOST ANTERIOR SUTURE PLACED ON THE PATIENT'S LEFT SIDE AND BECAME LODGED IN THE PATIENT'S TISSUE. BOTH PALPATION AND SUCTION WERE USED TO LOCATE THE NEEDLE, BUT THE PHYSICIAN WAS UNSUCCESSFUL. THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT. IT IS UNKNOWN WHETHER THIS OR ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS TO THE PATIENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE." THE PATIENT ALSO HAD A VAGINAL HYSTERECTOMY AND A URETHRAL SLING PLACED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI UNK55

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other POLYPROPYLENE 48-INCH SIZE 0 CAPIO SUTURE