BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2183260 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03091
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 24, 2011
    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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INCOMPLETE/INTERRUPTED FIRING. THE LONG60A DEVICE WAS RECEIVED FOR ANALYSIS WITH THE SHROUDS DAMAGED AND WITH AN ECR60D CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH THE RETURNED CARTRIDGE RELOAD BY RESETTING AND RELOADING IT INTO THE DEVICE. THE DEVICE ACHIEVED ITS COMPLETE STROKE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS THE ANVIL RELEASE BUTTON WORKED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO HOW THE SHROUDS BECAME DAMAGED; IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THE SURGEON COULD NOT ACTIVATE THE DEVICE. THE RELEASE LEVER DID NOT OPERATE. THE SURGEON OPENED A NEW DEVICE TO FINISH THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? THE INSTRUMENT WAS NOT PLACED ON THE TISSUE. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.) BEFORE DR (B)(6) PLACED THE INSTRUMENT ON THE TISSUE, HE RECOGNIZED THAT THE FIRING TRIGGER DIT NOT WORK . WHAT COLOR CARTRIDGE WAS BEING USED? THE GOLD CARTRIDGE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? THE SAME COLOR CARTRIDGE (NEW CARTRIDGE) WITH A NEW INSTRUMENT. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WAS THERE ANY TISSUE DAMAGE? HAD ADDITIONAL TISSUE BE REMOVED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60D, LOT # K4392U