BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2081561 · Received May 9, 2011

    Report

    Report Number
    3005099803-2011-01652
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS USED DURING A SACROSPINOUS FIXATION PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE CARRIER DETACHED INSIDE THE PATIENT. THIS OCCURRED ON THE SECOND THROW OF THE DEVICE; THE PHYSICIAN HAD THROWN ONE SUTURE SUCCESSFULLY BEFORE. IT WAS REPORTED THAT THE NEEDLE CARRIER DID NOT APPEAR BENT. THE CARRIER FRAGMENT WAS RETRIEVED FROM THE PATIENT. AT THIS POINT, THE FIXATION HAD BEEN COMPLETED, SO ANOTHER DEVICE WAS NOT REQUIRED. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 0013833862

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention