BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGIA ULTRA UNIVERSAL STAPLER

    MDR report key: 3170188 · Received June 7, 2013

    Report

    Report Number
    1219930-2013-00439
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 20, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SUR
    Product Code
    GDW
    PMA / PMN Number
    K101444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: AFTER THE DEVICE WAS FIRED, THE JAW DID NOT OPEN. THE JAW HAD TO BE OPENED BY FORCE USING HAND INSTRUMENT, WHICH CAUSED THE TISSUE TO RIP AND BLEED. HE HAD TO USE HAND SUTURE TO RECOVER THE BLEEDING. THE SURGEON USED ANOTHER PRODUCT FOR REMAINING OF THE PROCEDURE. NO REINFORCEMENT MATERIAL WAS USED IN CONJUNCTION WITH THE DEVICE, NO UNANTICIPATED TISSUE LOSS, NO BLOOD LOSS OF 500CC OR MORE, SURGICAL TIME WAS NOT EXTENDED BY MORE THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253829 EGIA ULTRA UNIVERSAL STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SUR N2L0030UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention LOT #N2L0087ULX, EXPIRATION DATE: 11/30/2017| MANUFACTURE DATE: 11/2012, K083519| EGIA 60 ARTICULATING MED/THICK SULU: EGIA60AMT