BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60

    MDR report key: 2240625 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03701
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 14, 2011
    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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INCOMPLETE/INTERRUPTED FIRING CYCLE THE ANALYSIS RESULTS SHOWED THAT TWO ECR60G CARTRIDGE RELOADS WERE RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND PARTIALLY FIRED. THE RETURNED CARTRIDGE RELOADS WERE TESTED FOR FUNCTIONALITY BY RESETTING AND LOADING THEM INTO A TEST DEVICE. THE FUNCTIONAL TEST DEMONSTRATED THAT THE REMAINING STAPLES IN THE CARTRIDGE RELOAD FORMED PROPERLY AND THE INSTRUMENT ACHIEVED ITS COMPLETE 3-STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE MALFORMED AT THE FIRST STROKE OF SECOND FIRING. CHANGED ANOTHER RELOAD UNIT BUT STILL FAILED AT THE FIRST STROKE. CHANGED THE THIRD RELOAD UNIT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL FOLLOWUP: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? LOBE OF THE LUNG. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? YES. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NEAR AN EXISTING STAPLE LINE ON THE 1ST AND 3RD FIRING. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. 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? NO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1