BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR STAPLER

    MDR report key: 3851880 · Received June 5, 2014

    Report

    Report Number
    3005075853-2014-03812
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    April 16, 2014
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE TX60G DEVICE ARRIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT. RELOAD WAS RECEIVED PARTIALLY LOADED WITH ONLY 4 STAPLES PRESENT AND ALL PROTRUDING. IT SHOULD BE NOTED THAT WHEN MANIPULATING THE DEVICE ONLY THE CLOSING TRIGGER SHOULD BE GRASP 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. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    THE DEVICE RECEIVED HAS BEEN CONSIDERED AS AN UN-RECONCILED BLIND UNIT. NO FURTHER INFORMATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328969 PROXIMATE LINEAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1