BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA XL 28MM SINGLE-USE STAPLER

    MDR report key: 3800207 · Received April 28, 2014

    Report

    Report Number
    2647580-2014-00320
    Event Type
    Injury
    Date Received
    April 28, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 11, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO, INC.
    Product Code
    GAG
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE ROBOTIC SIGMOID RESECTION. ACCORDING TO THE REPORTER: THE STEPS TO FIRE THE EEA STAPLER WERE FOLLOWED. MATED THE ANVIL TO THE TROCAR OF THE STAPLER, THE ORANGE BAND WAS COVERED, THE TROCAR AND ANVIL MATED TO THE STAPLER, GREEN LINE WAS VIEWED, THE SAFETY WAS RELEASED, FIRED, HEARD CRUNCH, THE INSTRUMENT WAS TURNED 2 FULL TURNS, HEARD THE CLICK AND REMOVED THE STAPLER. THE STAPLES WERE NOT FORMED INTO THE "B" SHAPE FOR 80% OF THE CIRCUMFERENTIAL PORTION OF THE ANASTOMOSES. SOME FORMED ON THE POSTERIOR SIDE NEAR THE RECTUM. THE RECTAL STUMP WAS HAND SEWN. A SECOND EEA WAS FIRED. THE SECOND TIME THERE WERE POORLY FORMED DONUTS IN BOTH THE PROXIMAL AND DISTAL PORTIONS OF THE DONUTS. HALF THE ANASTOMOSIS WAS OVERSEWN, THEN INVERTED TWO LAYERS OF THE FINAL ANASTOMOSES TO PROTECT THE INTEGRITY OF IT. A FINAL RIGID PROCTOSCOPE WAS PERFORMED AND NO APPARENT BUBBLES WERE SEEN. THERE WAS UNANTICIPATED TISSUE LOSS AND EXTENDED OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253729 EEA XL 28MM SINGLE-USE STAPLER DISPOSABLE SURGICAL STAPLING DEVICE GAG COVIDIEN, FORMERLY USSC PUERTO RICO, INC. P0K0181H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention