BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETRIO

    MDR report key: 3902703 · Received June 30, 2014

    Report

    Report Number
    3005075853-2014-04491
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED WITH THE JAWS STUCK IN THE CLOSED POSITION WITH A CLIP STUCK BETWEEN THE JAWS AND WITH THE HANDLE SLIGHTLY OPENED FROM TOP OF THE SHROUDS IN WITH THE LEVER SWITCH IN THE UNLOCKED POSITION. DUE TO THE RETURNED CONDITION, THE JAWS WOULD NOT OPEN AND CLOSE AND NO OTHER FUNCTIONAL TESTING COULD BE PERFORMED. THE HANDLES WERE FORCE TO OPEN TO TAKE A LOOK OF THE BATCH NUMBER. IF THE DEVICE WAS ACTIVATED ACROSS A CLIP, STAPLE LINE OR OTHER METAL IN THE JAWS, THIS WOULD CAUSE THE "REPOSITION AND REACTIVATE" AN ALERT SCREEN TO APPEAR ON THE GENERATOR, FOLLOWED BY THE "REPLACE INSTRUMENT" ALERT SCREEN. OUR INSTRUCTIONS FOR USE STATE: ¿ AVOID CONTACT WITH METAL AND PLASTIC WHEN INSTRUMENT IS ACTIVE.¿ AND ¿USING EXCESSIVE FORCE ON THE HANDLE COULD DAMAGE THE DEVICE.¿

    Additional Manufacturer Narrative · 1

    (B)(4). 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. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP LOBECTOMY, THE JAWS CLAMPED A CLIP AT THE END OF OPERATION. ALTHOUGH NO ERROR CODE WAS DISPLAYED, THE HANDLE DID NOT RETURN TO THE HOME POSITION WITH THE JAWS CLAMPING THE CLIP. THE DEVICE WAS REMOVED FROM THE PATIENT BY RESECTING THE FAT TISSUE AROUND THE JAWS. THE HANDLE WAS TRIED TO RETURN TO THE HOME POSITION ON THE MAYO STAND, BUT IT COULD NOT RETURN AND IT WAS FOUND THAT THE HANDLE WAS DAMAGED. THERE WAS NO BLEEDING DUE TO THE EVENT. RF60 WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE DOCTOR COMMENTED THAT THE FRAGMENT WAS NOT LEFT INSIDE THE PATIENT BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379013 ETRIO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. UNK K4DV8X

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR