BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3122688 · Received May 21, 2013

    Report

    Report Number
    3005075853-2013-02467
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 30, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE I-BLADE OUT OF THE BUTTON JAW AND THE ELECTRODE SEPARATED. 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 I BLADE. THE CONDITION OF THE BLADE PREVENTED THE FUNCTIONALITY OF THE JAW. THE JAW WAS UNABLE TO OPEN AND CLOSE. IT IS POSSIBLE THAT A REPLACE INSTRUMENT WAS NOTED DURING USAGE WITH THE ELECTRODE SEPARATED IN THIS MANNER. THIS WAS NOT CONFIRMED DURING COMPLAINT ANALYSIS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED FOR ANALYSIS, A SUPPLEMENTAL MEDWATCH WILL BE SENT

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE THERE WAS AN ERROR CODE: ¿REPLACE INSTRUMENT¿ AND BLADE WAS DEFORMED; WITH GEN11. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223943 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4CD6E

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR