BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM

    MDR report key: 3062947 · Received April 17, 2013

    Report

    Report Number
    3005075853-2013-01837
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 28, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT DEVICE A AND B WERE RECEIVED IN GOOD CONDITION AND FULLY FIRED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. IN ADDITION, THE CARTRIDGES WERE DISASSEMBLED TO VERIFY THE INTEGRITY OF THE INTERNAL COMPONENTS AND NO ABNORMALITIES WERE NOTED. ADDITIONALLY A MALFORMED STAPLE WAS RECEIVED ATTACHED TO TAPE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. DEVICE B ADDITIONAL INFORMATION: BATCH # J5KF2A, EXPIRATION DATE: 11/21/2017, MANUFACTURING DATE: 12/21/2012.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WAS BUTTRESSING MATERIAL UTILIZED? NO. WERE ANY UNEXPECTED NOISES HEARD? 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? YES. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, ON THE FIRST APPLICATION OF THE INSTRUMENT ON THE ANTRUM OF THE STOMACH A MALFORMED STAPLE WAS OBSERVED ON THE EDGE OF THE GREATER CURVE ON THE SPECIMEN SIDE. THE TISSUE HAD BEEN INSERTED INTO THE JAWS EQUAL TO THE 55MM MARK SO IT WASN'T JAMMED DEEP INTO THE JAWS. THE SAME GUN WAS USED TO COMPLETE THE CASE AND ALL OTHER LOADS (INCLUDING ANOTHER BLACK) WORKED NORMALLY. AT THE END OF THE CASE A MALFORMED STAPLE WAS NOTICED ON ONE OF THE TWO BLACK RELOADS, SO BOTH WERE COLLECTED TO SEND IN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164909 ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60T