BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 4.8MM STAPLES

    MDR report key: 2090153 · Received May 6, 2011

    Report

    Report Number
    1219930-2011-00381
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K0830781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER: DOCTOR VENKAT WAS OPERATING THE STAPLER, AFTER FIXING ANVIL WITH PURSTRING SUTURE THEN FIXING THE STAPLE GUN, AND HE CHECKED THE ALIGNMENT AND FIRED. BUT STAPLER DID NOT FIRE OR CUT ANY TISSUE. HE OBSERVED ONLY 2 PINS BETWEEN 9-12 CLOCK POSITION. WHEN HE REMOVED THE STAPLER ALL THE REMAINING PINS FELL DOWN TO HIS HAND IN CLOSED POSITION. MEDICAL INTERVENTION WAS REQUIRED. SURGERY WAS EXTENDED BY MORE THAN 30 MINS. CURRENT CONDITION OF PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33MM HEMORRHOID STAPLER 4.8MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GDW UNITED STATES SURGICAL N0G0419UMR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention