BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX LONG 60

    MDR report key: 1960026 · Received December 30, 2010

    Report

    Report Number
    1960026
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    August 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN FOR LAP ROUX GASTRIC BYPASS. SURGEON USED ETHICON ECHELON FLEX60 LONG60A AND HAD PROBLEMS WITH TWO RELOADS CATALOG # ECR60B X2. HE HAD FIRED THE ECHELON FIVE TIMES WITHOUT PROBLEM. ON THE 6TH FIRING, HE BEGAN TO FIRE THE UNIT, THOUGHT HE FELT RESISTANCE AS THOUGH SOMETHING WAS BETWEEN THE TISSUE TOO THICK FOR THE STAPLER (MAYBE THE BOUGIE PASSED DOWN THE ESOPHAGUS BY ANESTHESIA), SO HE ABORTED THE FIRING. HE PLACED THE 7TH LOAD, REPOSITIONED AND FIRED, BUT ONLY GOT A PARTIAL FIRING. DEVICES, RELOADS AND WRAPPERS SAVED. SURGEON OVER SEWED THE AREA WHERE THE STAPLES FAILED AND WILL CONTINUE TO MONITOR PATIENT.MANUFACTURER RESPONSE FOR STAPLER, SURGICAL, ECHELON FLEX LONG 60: HAVE NOT HEARD BACK YET.MANUFACTURER RESPONSE FOR STAPLER, RELOAD, SURGICAL, ECHELON FLEX LONG 60: HAVE NOT HEARD BACK YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON FLEX LONG 60 STAPLER, SURGICAL GDW ETHICON ENDO-SURGERY, INC. LONG60A G4T918
    2 ECHELON FLEX LONG 60 STAPLER, RELOAD, SURGICAL GDW ETHICON ENDO-SURGERY, INC. ECR60B G4T573

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR