BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL G2 CURVED JAW

    MDR report key: 3170235 · Received June 14, 2013

    Report

    Report Number
    3005075853-2013-03014
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 4, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED WITH THE TIP OF THE I BLADE BROKEN AND NOT RETURNED. THE JAWS WERE FOUND IN GOOD VISUAL CONDITIONS. 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. NO YELLOW ALERT SCREENS WERE DISPLAYING DURING TESTING. THE CONDITION OF THE BLADE PREVENTED THE FUNCTIONALITY OF THE JAW. THE JAW WAS UNABLE TO OPEN AN CLOSE. 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). DATE SENT: (B)(4) 2013. INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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 LIVER RESECTION THE SURGEON WAS USING THE DEVICE FOR APPROX 30 MINUTES WITHOUT PROBLEMS AND THEN THE JAWS ON THE DEVICE LOCKED. GENERATOR ERROR MESSAGE READ ¿REPOSITION AND REACTIVATE¿. SURGEON COULD NOT OPEN THE JAWS OF THE DEVICE SO HE REMOVED IT FROM THE PATIENT. HE MANAGED TO RE-OPEN THE JAWS BUT INSTRUMENT WAS BROKEN AND JAWS NO LONGER WORKING. OPENED A DIFFERENT DEVICE TO COMPLETE THE CASE. NO ADVERSE EVENT REPORTED. THERE WAS A10 MINUTE DELAY IN SURGERY. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270721 ENSEAL G2 CURVED JAW ELECTROSURGICAL CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4CD1H

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR