BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROX ACCESS 55MM ART STAP THIC

    MDR report key: 1231187 · Received November 10, 2008

    Report

    Report Number
    3005075853-2008-02891
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/10/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LAR PROCEDURE, THE DEVICE WAS PLACED ON THE RECTUM VERY LOW IN THE PELVIS. THE DEVICE WAS FIRED AND THE TISSUE WAS RESECTED, BUT PRIOR TO INSERTING THE CIRCULAR STAPLER, THE SURGEON CHECKED THE STAPLE LINE WITH HIS FINGER AND FOUND A HOLE IN THE RECTAL STUMP. HE IS NOT CERTAIN WHETHER IT WAS A HOLE IN THE STAPLE LINE OR ANOTHER HOLE. THE SURGEON SUTURED THE DEFECT BY HAND AND COMPLETED THE ANASTAMOSIS AS INTENDED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX ACCESS 55MM ART STAP THIC GDW ETHICON ENDO-SURGERY, LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1