BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4241330 · Received November 10, 2014

    Report

    Report Number
    3005075853-2014-07794
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 22, 2014
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE SC60A DEVICE WAS RETURNED WITH THE CLAMPING MECHANISM DAMAGED AND WITH AN ECR60B CARTRIDGE RELOAD PRESENT. THE CARTRIDGE WAS RECEIVED FULLY FIRED. IN ADDITION THE INDICATOR DISK WAS NOTED DAMAGED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. HOWEVER, THE DEVICE WAS DISASSEMBLED TO VERIFY THE INTERNAL COMPONENTS AND THE YOKE WAS NOTED TO BE BROKEN. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE YOKE BECAME BROKEN, THIS DAMAGE CAN OCCUR WHEN EXCESSIVE FORCE IS APPLIED TO THE CLOSING TRIGGER WHEN THE JAWS ARE CLAMPED OVER AN EXCESS OF TISSUE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHEN THE FIRST DEVICE WOULD NOT OPEN, HOW WAS THE DEVICE REMOVED FROM TISSUE? DID THE JAWS OF THE DEVICE EVENTUALLY OPEN? WHEN THE FIRST DEVICE COULD NOT OPEN, THE SURGEON WANTED TO USE THE 2ND DEVICE TO CUT THE TISSUE AND REMOVE THE DEVICE. THE JAWS OF THE 1ST DEVICE ARE STILL CLOSED AND THE JAWS OF THE 2ND DEVICE WERE OPENED BY HIGH FORCE EVENTUALLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT FIRE AT THE THIRD STROKE OF THE FIRST FIRING WITH WHITE RELOAD; AND THE JAW COULD NOT OPEN. CHANGED ANOTHER DEVICE AND BLUE RELOAD, BUT THE KNIFE COULD NOT BACK TO THE ORIGINAL POSITION AFTER THE THIRD STROKE. THE JAW ALSO COULD NOT OPEN. THE SURGEON HAD TO CUT THE TISSUE AND REMOVED THE DEVICE. CHANGED TO HAND SEWING TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723614 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EA1E

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOADS - ECR60B, ECR60W