BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 STRAIGHT JAW

    MDR report key: 3113381 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02325
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 22, 2013
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. EVENT DATE - UNKNOWN, ASSUMED (B)(6) DAY OF MONTH ((B)(6) 2013) THAT COMPLAINT WAS REPORTED THE DEVICE WAS RECEIVED WITH THE TOP OF THE I-BLADE FRACTURED AND SLIGHTLY LIFTED AND THE UPPER JAW DETACHED AND NOT RETURNED. THE DEVICE WAS PARTIALLY TESTED WITH A GENERATOR AND THE DEVICE PERFORMED AS REQUIRED DURING TESTING; THOUGH ALL TESTING COULD NOT BE COMPLETED DUE TO THE DAMAGED OF THE I BLADE AND THE UPPER JAW. THERE IS INSUFFICIENT EVIDENCE RELATED TO WHAT CAUSED THE DAMAGE; A PROBABLE CAUSE OF THE DAMAGE TO THE I BLADE COULD BE NOT ALLOWING THICK AND FIBROUS TISSUES TO DENATURE PRIOR TO I-BLADE ADVANCEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, THE SURGEON TAPED THE BUTTON ON THE DEVICE DOWN TO AVOID HAVING TO KEEP PRESSING THE BUTTON THROUGHOUT THE CASE. THE TOP JAW IS BROKEN OFF COMPLETELY AND FELL INTO THE PATIENT. THE SURGEON FISHED OUT THE BROKEN JAW HOWEVER IT IS UNKNOWN HOW THE PIECE WAS REMOVED. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. NO ADVERSE CONSEQUENCES REPORTED. ONE DEVICE WILL BE RETURNED. NO OTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215294 ENSEAL G2 STRAIGHT JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4C80J

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR