BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC / COVIDIEN

    MDR report key: 6710505 · Received July 11, 2017

    Report

    Report Number
    MW5070952
    Event Type
    Malfunction
    Date Received
    July 11, 2017
    Date of Event
    January 1, 2017
    Report Date
    June 6, 2017
    Manufacturer
    COVIDIEN
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2017. ON (B)(6) 2017, PT HAD ABD PAIN AND HAD A DIAGNOSTIC LAPAROSCOPY. AN OPEN STAPLE FROM AN ENDO STAPLER WAS FOUND AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485136 MEDTRONIC / COVIDIEN ENDO GIA 30 MM TAN GAG COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR