BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA 60 ARTICULATING MED/THICK SULU

    MDR report key: 3902271 · Received June 25, 2014

    Report

    Report Number
    1219930-2014-00470
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 5, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES SURGICAL
    Product Code
    GAG
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC COLECTOMY. ACCORDING TO THE REPORTER: AFTER THE FIRST FIRING WAS DONE, A PERSON IN SUPPLIER CONFIRMED INCOMPLETE STAPLE LINE: A HALF PART OF STAPLES ON THE PROXIMAL PART COULD NOT BE FIRED ON TISSUE. REPORTED THE HANDLE COULD BE FULLY SQUEEZED TO THE END. NEW RELOAD WAS OPENED TO COMPLETE THE CASE. ADDITIONAL TISSUE RESECTION WAS REQUIRED FOR RECOVERY. THE REMAINDER OF THE CASE WAS COMPLETED WITH NO PROBLEM. THE SURGICAL INCISION WAS EXTENDED BY SMALLER THAN 3 CM. IT IS UNKNOWN IF REINFORCEMENT MATERIAL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370293 EGIA 60 ARTICULATING MED/THICK SULU DISPOSABLE SURGICAL STAPLER GAG COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES SURGICAL N3L0335X

    Patients

    Seq Age Sex Outcome Treatment
    1