BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS, 29MM, CURVED

    MDR report key: 3900224 · Received June 27, 2014

    Report

    Report Number
    3005075853-2014-04479
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    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). RESULTS FOUND THAT THE ECS29A DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE ANVIL HALF WASHER WAS PRESENT AND CUT INDICATING THAT THE INSTRUMENT ACHIEVED A FULL FIRING STROKE; HOWEVER THE INSTRUMENT WAS RECEIVED FULLY LOADED WITH STAPLES. A NEW WASHER WAS PLACED ON THE INSTRUMENT AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE ANVIL WAS ATTACHED ON THE DEVICE COMPLETELY AND WITHOUT ANY DIFFICULTIES AND DID NOT DETACH DURING FUNCTIONAL TESTING. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE WASHER WAS CUT WITHOUT THE INSTRUMENT DEPLOYING THE STAPLES, IT IS POSSIBLE THAT THE RETURNED ANVIL DOES NOT BELONG TO THE RETURNED DEVICE. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON ATTEMPTED TO CONNECT THE ANVIL TO THE STAPLER AND THE TWO COMPONENTS WOULD NOT LOCK TOGETHER. THE SURGEON REMOVED THE STAPLER AND OPENED A NEW DEVICE OF SAME CODE AND WAS ABLE TO CONNECT THE NEW STAPLER TO THE FIRST ANVIL THAT WAS ALREADY IN PLACE IN THE PATIENT. THE CASE WAS COMPLETED WITH FIRST ANVIL AND NEW STAPLER. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378132 ENDO ILS, 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EG2Z

    Patients

    Seq Age Sex Outcome Treatment
    1