BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM

    MDR report key: 1923764 · Received December 14, 2010

    Report

    Report Number
    3005075853-2010-07051
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 25, 2010
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLES WERE NOTED TO HAVE A PROPER B-FORMATION AND THE STAPLE LINE WAS COMPLETE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESTORATIVE PROCTOCOLECTOMY AND LOOP ILEOSTOMY PROCEDURE, THE DEVICE WAS CLOSED ON THE BOWEL, FIRED, AND THEN A CUT WAS DONE ON THE PROXIMAL SIDE. WHEN THE DEVICE WAS OPENED, THERE WERE NO STAPLES PRESENT AND NO STAPLE LINE. THE BOWEL WAS OPEN. ANOTHER DEVICE WAS USED TO STAPLE THE RECTUM LOWER DOWN. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER - 30 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TJ3G

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE