BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2214048 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03346
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 28, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PREMATURE SLED MOVEMENT. THE LONG60A DEVICE WAS RECEIVED FOR ANALYSIS WITH NO VISUAL NON-CONFORMANCES AND WITH AN ECR60G CARTRIDGE RELOAD PRESENT. THE CARTRIDGE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10. IN ADDITION A 12 MM XCEL TROCAR WAS RECEIVED. IT IS POSSIBLE THAT WHILE LOADING THE RELOAD, THE CARTRIDGE WAS PUSHED FARTHER BACK THAN THE CARTRIDGE ALIGNMENT STOP WINDOWS RESULTING IN THE KNIFE PUSHING THE ONE PIECE SLED FORWARD AND LOCKING THE CARTRIDGE. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. THE RETURNED DEVICE AND CARTRIDGE RELOAD WERE TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION 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 DEVICE OPENED AND CLOSED WITHOUT ANY DIFFICULTIES NOTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A GASTRIC SLEEVE PROCEDURE. THE DEVICE WOULD NOT OPEN. THE DEVICE WAS ON TISSUE, BUT IT IS UNKNOWN HOW THE DEVICE WAS REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH AT WHAT LOCATION ON THE TISSUE? UNK. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? UNK. DURING WHICH STROKE DID THE EVENT OCCUR? UNK. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNK. WAS BUTTRESSING MATERIAL UTILIZED? UNK IF SO, WHICH PRODUCT? NA. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNK. WERE ANY UNEXPECTED NOISES HEARD? UNK IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? UNK. 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. WHAT WERE THE PATIENT'S PRE-EXISTING CONDITIONS? MORBID OBESITY. THEY MANEUVERED THE DEVICE AND IT CAME OFF THE TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43W72

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G