BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3951420 · Received July 22, 2014

    Report

    Report Number
    3005075853-2014-05160
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: NO CONFIRMATION. IF THE DEVICE WERE CLOSED AND THE FIRING TRIGGER WAS ACTUATED, IT IS POSSIBLE FOR THE DEVICE TO GET WARM, BUT NOT HOT ENOUGH TO "SMOKE". THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. DEVICE HAS CONSIDERABLE CORROSION FROM THE SALINE SOAKING. THE DEVICE WOULD NOT RUN - PRESUMABLY BECAUSE OF CORROSION INSIDE THE MOTOR. THE MOTOR WIRES WERE DISCONNECTED FROM THE RETURNED MOTOR AND A SAMPLE MOTOR GEARBOX WAS ATTACHED. THIS MOTOR RAN WHEN THE TRIGGERS WERE ACTUATED. THE PCBA WAS REMOVED AND EXAMINED. THERE WERE NO SIGNS OF HEAT DAMAGE, NO DISCOLORATION OF COMPONENTS OR SMELLS FROM HEAT. THERE IS A SMALL DISCOLORATION NEAR THE MIDDLE TWO RESISTORS. THERE ARE NEAR THE SW3 SOLDERING PARTS. A SAMPLE PCB ALSO HAD SIMILAR DISCOLORATION. THIS IS PRESUMED TO BE FROM SOLDERING SW3-EITHER HEAT OR FLUX FLOW. THE MOTOR WAS REMOVED FROM THE GEARBOX AND A CONTINUITY CHECK WAS COMPLETED ACROSS THE TERMINALS AS THE MOTOR WAS TURNED, THERE WERE "DEAD" SPOTS ON THE COMMUTATOR, A BATTERY WAS HOOKED TO THE MOTOR AND THE MOTOR BEGAN TO RUN. THE MOTOR MADE UNUSUAL SQUEAKING, MOST LIKELY FROM CORRODED BEARINGS ON THE MOTOR SHAFT. AFTER RUNNING THE TERMINAL CONTINUITY TEST WAS REPEATED AND THE DEAD SPOTS WERE GONE. IT IS PRESUMED RUNNING THE MOTOR CLEANED THE CORROSION FROM THE COMMUTATOR. THE MOTOR WAS DISASSEMBLED. THERE IS SIGNIFICANT CORROSION INTERNALLY, BUT NOTHING TO SUGGEST A SOURCE OF EXCESSIVE HEAT. NO CONCLUSION. NO CAUSE FOR EXCESSIVE HEAT COULD BE DETERMINED. THE PCBA WAS CONFIRMED TO CONTAIN THE CORRECTIVE ACTIONS DESIGN CHANGE WITH EXTRA CLEARANCE OF ELECTRICAL TRACE LAYER AROUND SCREWS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE 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 SUBTOTAL GASTRECTOMY PROCEDURE THE DEVICE HAD BEEN USED FOR THE PROCEDURE (4-5 TIMES) AND WAS SITTING ON THE BACK TABLE IN THE OR. THE REP WAS CALLED AS THE DEVICE WAS SMOKING AND POSSIBLY CATCHING ON FIRE. SALINE WAS POURED ON THE DEVICE AND THE SMOKING STOPPED. USE OF THE DEVICE WAS COMPLETED WHEN IT WAS PLACED ON THE BACK TABLE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428671 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1