BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2002683 · Received February 28, 2011

    Report

    Report Number
    3005099803-2011-00534
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: VISUAL INSPECTION: THE RETURNED DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS. FUNCTIONAL ANALYSIS: THE RETURNED DEVICE WAS ACTUATED WITH A SUTURE AND NEEDLE THREE TIMES AND NO ANOMALIES WERE OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE REPORTED EVENT COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A "REVISION REPAIR AFTER PREVIOUS VAG HYST AND ANT-POST REPAIR," AS THE PHYSICIAN WAS PASSING THE NEEDLE THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN REPORTEDLY "USED A MAYO NEEDLE AND PASSED THE SAME SUTURE THROUGH THE [SACROSPINOUS LIGAMENT]." THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A "REVISION REPAIR AFTER PREVIOUS VAG HYST AND ANT-POST REPAIR," AS THE PHYSICIAN WAS PASSING THE NEEDLE THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE PHYSICIAN REPORTEDLY "USED A MAYO NEEDLE AND PASSED THE SAME SUTURE THROUGH THE [SACROSPINOUS LIGAMENT]." THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-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 M0068312321 13244046

    Patients

    Seq Age Sex Outcome Treatment
    1 MAYO NEEDLE