BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6020004

    MDR report key: 6020004 · Received October 12, 2016

    Report

    Report Number
    6020004
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 27, 2016
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY IN THE GENERAL OPERATING ROOM, THE ENDO GIA REINFORCED RELOAD SURGICAL STAPLER FAILED TO FIRE AND THE JAWS LOCKED. THE LOAD BEING USED WAS A BLACK LOAD COVERED WITH SEAMGUARD. THE THICKNESS OF THE TISSUE ATTEMPTING TO BE STAPLED WAS NOT NOTED. THE STAPLER LATER SUCCESSFULLY FIRED A SERIES OF BLACK AND PURPLE CARTRIDGES. THERE WAS NO HARM TO THE PATIENT. MANUFACTURER RESPONSE FOR ENDO GIA REINFORCED RELOAD SURGICAL STAPLER, ENDO GIA REINFORCED RELOAD SURGICAL STAPLER (PER SITE REPORTER): REP WAS E-MAILED AND THE DEVICE WAS COLLECTED.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR