BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60

    MDR report key: 2931563 · Received January 28, 2013

    Report

    Report Number
    3005075853-2013-00339
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? THICK. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? SEOND. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? ASKU, THE SURGEON WAS NOT SURE WHICH STROKE. WHAT COLOR CARTRIDGE WAS BEING USED? BLACK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? BLACK. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ACROSS. WERE ANY UNEXPECTED NOISES HEARD? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? OPENING WAS HIGHER. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? FELT THE TISSUE WAS TOO THICK.

    Additional Manufacturer Narrative · 1

    (B)(4). BUCKLED KNIFE AND DAMAGED ANVIL THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH THE ANVIL DAMAGED THE FIRING MECHANISM JAMMED. THE DEVICE WAS RECEIVED WITH AN ECR60T RELOAD PRESENT. THE RELOAD WAS RECEIVED PARTIALLY FIRED, WITH THE CARTRIDGE BODY, DRIVERS AND ONE PIECE SLED DAMAGED. AFTER FURTHER ANALYSIS IT WAS NOTED THAT THE KNIFE HAD BUCKLED. THE DAMAGE TO THE CARTRIDGE, KNIFE AND ANVIL IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER AN EXCESS OF TISSUE, CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE KNIFE WILL BUCKED, AND AS THE KNIFE IS ATTEMPTING TO PULL THE ANVIL TOWARDS THE CARTRIDGE TO FORM THE STAPLES IT WILL RESULT IN THE DAMAGE OBSERVED ON THE ANVIL. 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 RIGHT UPPER LOBE PROCEDURE, THE SURGEON CLOSED THE DEVICE ON TISSUE WITH A BLACK LOAD AND FIRED AND THOUGHT THE FIRING STROKES WERE COMPLETED. THE SURGEON PUT THE DEVICE IN REVERSE AND TRIED TO SQUEEZE AND THE DEVICE WOULD NOT OPEN. THE SURGEON PLACED A COMPETITOR'S DEVICE NEXT TO THE EES DEVICE AND THE COMPETITOR'S DEVICE BROKE IMMEDIATELY. THE SURGEON THEN PLACED A POWERED DEVICE WITH A BLACK LOAD NEXT TO THE DEVICE THAT WOULD NOT OPEN AND FIRED. THE DEVICE WAS REMOVED AND IS STILL IN THE CLOSED POSITION. THERE WAS NO IMPACT TO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36742 ECHELON*FLEX60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CN59

    Patients

    Seq Age Sex Outcome Treatment
    1