BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLY GIA* 75-.060 STAPLER (ABSORBABLE)

    MDR report key: 4143470 · Received October 6, 2014

    Report

    Report Number
    1219930-2014-00920
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    October 30, 2013
    Report Date
    September 12, 2014
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GDW
    PMA / PMN Number
    K013860
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: COLOSTOMY TAKEDOWN. ACCORDING TO THE REPORTER: THE PHYSICIAN FIRED THE GIA 75 BUT IT DID NOT RETRACT LIKE IT WAS SUPPOSED TO. HE HAD TO MANUALLY RETRACT THE STAPLER. HE THEN FIRED ANOTHER STAPLER JUST DISTAL TO DETERMINE IF HARM HAD BEEN DONE TO THE PATIENT BY THE MISFIRE. HE WAS UNABLE TO VISUALIZE ANY DAMAGE OR HARM TO THE PATIENT. PATIENT STATUS: STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622325 POLY GIA* 75-.060 STAPLER (ABSORBABLE) DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL A DIVISON 030775

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other