BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2872480 · Received December 13, 2012

    Report

    Report Number
    3005099803-2012-06062
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE NEEDLE DID NOT PASS THROUGH APPROPRIATELY AFTER THREE ATTEMPTS (SPECIFICS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - COSTA RICA (COYOL) M0068311250 15358929

    Patients

    Seq Age Sex Outcome Treatment
    1