BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH STAPLER

    MDR report key: 3943416 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05069
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLOSING TRIGGER. THE EC60 DEVICE WAS RECEIVED FOR ANALYSIS IN GOOD VISUAL CONDITION AND WITH A CARTRIDGE RELOAD LOADED ON THE DEVICE. THE RELOAD WAS RECEIVED FULLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. DURING THE ANALYSIS IT WAS NOTED THAT THE CLOSING TRIGGER WOULD NOT RETURNED IT TO HOME POSITION. THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS; THE CLOSURE TRIGGER RETURN SPRING POST WAS DAMAGED AND THE CLOSURE TRIGGER SPRING WAS DISENGAGED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE CLAMPING MECHANISM BECAME DAMAGED, IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THAT THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC HEMI COLECTOMY PROCEDURE, THE CIRCULATING NURSE CONTACTED THE REP DURING THE PROCEDURE. THE DEVICE WAS STUCK ON A VESSEL. THE SURGEON WAS ASKING FOR ASSISTANCE IN HOW TO RELEASE IT FROM THE VESSEL. THE SURGEON HAD FIRED THE DEVICE 3 TIMES AS REQUIRED; HOWEVER, WHEN HE DEPRESSED THE BACK RELEASE BUTTON IT WOULD NOT DISENGAGE THE JAW. HE TRIED THE MANUAL RELEASE BUT IT WAS NOT CATCHING. THEY ATTEMPTED PULLING MANUAL RELEASE SEVERAL TIMES, BUT IT STILL WOULD NOT RELEASE. EVENTUALLY THE SURGEON WAS ABLE TO RELEASE THE DEVICE FROM THE VESSEL BY PLAYING WITH THE BUTTON THAT INDICATED THAT HE STROKED THE STAPLER 3 TIMES. THE INDICATOR SHOWING THAT THE DEVICE WAS NOT QUITE STROKED A FULL 3 TIMES - SOMEWHERE IN BETWEEN 2 AND 3. AFTER FIDDLING WITH IT AND THEN HITTING THE RELEASE BUTTON THE JAW OPENED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422398 ECHELON 60 ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60W