BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 2930223 · Received January 25, 2013

    Report

    Report Number
    3005075853-2013-00318
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    October 29, 2012
    Report Date
    October 29, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K112033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUMENT WAS RECEIVED WITH THE ENERGY BUTTON DETACHED AND RETURNED WITH THE INSTRUMENT. THE BUTTON WAS REATTACHED TO THE INSTRUMENT AND TESTED WITH THE GENERATOR. THE INSTRUMENT WAS RECOGNIZED BY THE GENERATOR BUT DURING FUNCTIONAL TESTING, THE INSTRUMENT DID NOT ACTIVATE WITH THE GENERATOR. IT WAS DISASSEMBLED AND IT WAS NOTED THAT THE ACTIVATION WIRE WAS CUT. THE DAMAGED WIRE KEPT THE INSTRUMENT FROM WORKING WITH THE GENERATOR. OUR MANUFACTURING PROCESS VERIFIES THE PRESENCE AND FUNCTIONALITY OF THE INSTRUMENT PRIOR TO SHIPPING. NO CONCLUSION COULD BE REACHED AS TO HOW THE BUTTON DETACHED FROM THE INSTRUMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC SLEEVE PROCEDURE, THE SURGEON WENT TO ACTIVATE FOR THE FIRST FIRING; DEVICE WOULD NOT DELIVER ENERGY. REACTIVATE, TWO SWITCH ACTIVATIONS DETECTED. TROUBLESHOOTED ISSUE (SWITCHED TO HAND ACTIVATION ONLY) BUT ISSUE PERSISTED. A SECOND DEVICE WAS OPENED AND OPERATED JUST FINE THROUGHOUT CASE. THERE WERE NO PATIENT CONSEQUENCES. ONE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35613 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK J4AV6G

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR