BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON ENDO-SURGERY INC

    MDR report key: 4283268 · Received November 11, 2014

    Report

    Report Number
    4283268
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 13, 2014
    Report Date
    November 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY INC
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ECHELON FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER FIRED BY SURGEON; ONCE STAPLES APPLIED, THE INSTRUMENT JAW FAILED TO OPEN/RELEASE. SURGEON HAD TO KEEP MANIPULATING RELEASE BUTTON UNTIL IT FINALLY RELEASED.======================MANUFACTURER RESPONSE FOR LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, ECHELON FLEX 60 (PER SITE REPORTER).======================REPORTER NOT AWARE OF RESPONSE FROM SALES REP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726651 ETHICON ENDO-SURGERY INC STAPLER, SURGICAL GAG ETHICON ENDO-SURGERY INC * L91785

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR