BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA AUTOSTAPLER

    MDR report key: 558642 · Received November 29, 2004

    Report

    Report Number
    558642
    Event Type
    Malfunction
    Date Received
    November 29, 2004
    Date of Event
    November 15, 2004
    Report Date
    November 29, 2004
    Manufacturer
    ENDO GIA AUTOSUTURE STAPLER
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENDO GIA AUTOSUTURE DEVICE SHOULD BE ABLE TO BE RELOADED FOR 4 POSSIBLE USES. VERY EXPERIENCED OR NURSE WAS UNABLE TO RELOAD DEVICE. NURSE'S DESCRIPTION OF PROBLEM "JAWS OF THE STAPLER WERE NOT OPENING".

    Description of Event or Problem · 1

    THE INVESTIGATION PROCESS FOR THE ENDO GIA UNIVERSAL STAPLING SYSTEM HAS ROUTINELY CONCLUDED THAT THE ROOT CAUSE ANALYSIS FOR THE COMPLAINT OF "DIFFICULT TO LOAD" OR JAWS WILL NOT OPEN" IS THAT THE SULU WAS NOT ENGAGED PROPERLY WHEN LOADED. IN ADDITION, THE FOLLOWING ARE POTENTIAL CAUSES FOR THE INABILITY TO OPEN THE JAWS: JAWS HAVE BEEN MANUALLY CLAMPED PRIOR TO LOADING SULU WITH THE INSTRUMENT FIRING ROD EXTENDED. THE DEVICE IS UNAVAILABLE FOR EVALUATION, AS IT WAS DISCARDED BY THE REPORTING FACILITY. NO DESIGN CHANGES OR MODIFICATIONS HAVE BEEN MADE TO THE DEVICE SINCE FIRST MARKETED. AS PART OF THE CO'S ROUTINE POST - MARKET SURVEILLANCE PROCESS, CO HAS RE - ASSESSED THE ENDO GIA UNIVERSAL STAPLING SYSTEM AND HAVE CALCULATED THE INCIDENT RATE WITH RESPECT TO PT INJURY ASSOCIATED WITH THE REPORTED CONDITION OF "DIFFICULT TO LOAD" AND "JAWS WILL NOT OPEN" BY SEARCHING CO'S COMPLAINT TRACKING DATABASE FROM 2003 TO 2005 FOR ONLY THOSE COMPLAINTS WITH THE REPORTED CONDITION OF "DIFFICULT TO LOAD" AND "JAWS WILL NOT OPEN", WHICH WERE ASSOCIATED WITH A PT INJURY. ACCORDING TO THESE FIGURES, CO HAVE DETERMINED THE INCIDENT RATE FOR THE ENDO GIA UNIVERSAL STAPLING SYSTEM TO BE NON-EXISTENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA AUTOSTAPLER ENDO GIA AUTOSTAPLER GAG ENDO GIA AUTOSUTURE STAPLER ENDOGIA POWERED AUTOSUTURE *

    Patients

    Seq Age Sex Outcome Treatment
    1 *