BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 4.8MM STAPLES

    MDR report key: 2953937 · Received February 6, 2013

    Report

    Report Number
    1219930-2013-00069
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    November 7, 2012
    Report Date
    January 29, 2013
    Manufacturer
    COVIDIEN LP, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083781
    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: AFTER COMPLETING THE PURSE STRING SUTURE, THE SURGEON TRIED TO CONNECT THE STAPLER SET WITH THE ANVIL. HE CONFIRMS THE CLICK SOUND AND THEN TRIED TO CLOSE THE STAPLER. AFTER THE 3RD FIRING, THE STAPLER DISCONNECTED AND A NEW STAPLER WITH PREVIOUS ANVIL WAS USED TO COMPLETE THE PROCEDURE. PRODUCT WAS TESTED PRIOR TO USE. NO REINFORCEMENT MATERIAL USED. THERE WAS IRREVERSIBLE TISSUE DAMAGE. THE PROCEDURE TOOK MORE THAN TWO HOURS AND THE PATIENT HAD TO STAY BACK FOR TWO MORE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49578 33MM HEMORRHOID STAPLER 4.8MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY US SURGICAL N2C241UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O