BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2183324 · Received July 28, 2011

    Report

    Report Number
    3005099803-2011-02665
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE EDGE OF THE GRAY HANDLE WAS BROKEN. A FUNCTIONAL ANALYSIS OF THE DEVICE REVEALED NO DEFECTS. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PHYSICIAN DID NOT CONSIDER THE AMOUNT OF BLOOD LOSS TO BE CLINICALLY SIGNIFICANT AND THAT THE BLEEDING WAS NOT CAUSED BY THE CAPIO DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS USED DURING AN ANTERIOR/POSTERIOR REPAIR PROCEDURE. ACCORDING TO THE COMPLAINANT, THE DEVICE HAD A BROKEN PIECE. IT IS UNKNOWN WHAT PORTION OF THE DEVICE WAS BROKEN AND HOW IT BROKE. IT WAS REPORTED THAT THE PATIENT HAD EXCESS BLEEDING DURING THE PROCEDURE. IT IS UNKNOWN HOW THE BLEEDING WAS TREATED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO DEVICE AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AND PATIENT AS MFR REPORTS # 3005099803-2011-02663 AND 3005099803-2011-02664. THIS REPORT PERTAINS TO THE THIRD OF THREE DEVICES. THE PATIENT AGE WAS REPORTED TO BE OVER (B)(6) YEARS. ACCORDING TO THE COMPLAINANT, THE BROKEN PART OF THE DEVICE WAS THE HANDLE. THE HANDLE DID NOT DETACH FROM THE DEVICE BUT THE BROKEN PART WAS NOT NOTICED BEFORE THE DEVICE WAS INTRODUCED INTO THE PATIENT. THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION FOR THE BLOOD LOSS. THE PHYSICIAN TREATED THE BLEEDING WITH PRESSURE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI M0068311250 13979937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other