BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM

    MDR report key: 2221452 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03475
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT. 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. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RETURNED FOR ANALYSIS. EVENT COULD NOT BE CONFIRMED AS THE DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAW WAS STUCK. THE SURGEON USED EXTRA FORCE TO REOPEN THE JAW. THE FORMATION OF THE STAPLES WAS BAD. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA C4E59P

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE