BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*LINEAR STAP RELOAD

    MDR report key: 2222162 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03489
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 25, 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). CARTRIDGE DRIVERS PARTIALLY ADVANCED. THE ANALYSIS RESULTS SHOWED THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH TWO RELOADS PRESENT. RELOAD A WAS RECEIVED FULLY FIRED; RELOAD B WAS RECEIVED WITHOUT STAPLES AND WITH THE DRIVERS PARTIALLY ADVANCED. IT SHOULD BE NOTED THAT WHEN MANIPULATING THE DEVICE, ONLY THE CLOSING TRIGGER SHOULD BE GRASPED UNTIL READY TO FIRE THE DEVICE. DO NOT GRASP THE FIRING TRIGGER BEFORE THE DEVICE IS TO BE FIRED. IF THE FIRING TRIGGER IS MANIPULATED, IT COULD CAUSE THE STAPLES TO DEPLOY PARTIALLY OR COMPLETELY RESULTING IN MALFORMED STAPLES AND A PREMATURE LOCKOUT SITUATION. FOR FURTHER DETAILS, PLEASE REFER TO THE INSTRUCTION FOR USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN WEDGE PROCEDURE, SURGEON USED THE FIRST CARTRIDGE AND THE STAPLES WERE NOT FORMED; USED A SECOND CARTRIDGE WHICH DIDN'T FORM EITHER. FINALLY, THE THIRD CARTRIDGE WAS OK. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*LINEAR STAP RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4RW26

    Patients

    Seq Age Sex Outcome Treatment
    1 DEVICE