BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVIDIEN

    MDR report key: 5145184 · Received September 9, 2015

    Report

    Report Number
    5145184
    Event Type
    Injury
    Date Received
    September 9, 2015
    Date of Event
    June 15, 2015
    Report Date
    September 8, 2015
    Manufacturer
    COVIDEN / MEDTRONIC
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2015. HE REQUIRED ADDITIONAL PROCEDURE (AT ANOTHER FACILITY ON THE MAINLAND) DUE TO COMPLICATION FROM THE LAPAROSCOPIC APPENDECTOMY. IT WAS FOUND THAT ONE OF THE FIRED STAPLES, WAS FOUND LEFT OPEN (WITHOUT THE TIPS CURLED AROUND TISSUE). THE RAW TIP OF THE STAPLE HAD GOTTEN CAUGHT ON THE TERMINAL ILEUM AND CAUSED AN OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597979 COVIDIEN ENDO GIA 45 TAN / ENDO GIA 60 PURPLE GDW COVIDEN / MEDTRONIC 45-TAN EGI45AVM 60-PURPLE EGIA60AMT

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R