BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33MM HEMORRHOID STAPLER 4.8MM STAPLES

    MDR report key: 2892205 · Received December 21, 2012

    Report

    Report Number
    1219930-2012-00999
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    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: THIS IS A CASE OF 3RD DEGREE HEMORRHOIDS. AFTER COMPLETING THE PURESTRING SUTURE, SURGEON TRIED TO CONNECT THE STAPLER SET WITH THE ANVIL. HE HEARD THE CLICK SOUND AND TRIED TO CLOSE THE STAPLER BUT IT WAS NOT APPROXIMATING PROPERLY AND WAS POPPING OUT. SURGEON MANAGED TO APPROXIMATE AND FIRED THE DEVICE, BUT THE STAPLE WAS NOT WELL FORMED. PROCEDURE WAS COMPLETED BY USING CONVENTIONAL AND OPEN TECHNIQUE. THERE WAS SMALL VESSEL BLEEDING DUE TO THE STAPLE PENETRATED THE SUB MUCOSAL LAYER OF RECTUM AND THE SURGEON MANAGED THE PATIENT WITH BIPOLAR. CURRENT PATIENT CONDITION OK. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. EXTENDED THE HOSPITAL STAY FOR 2 MORE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 33MM HEMORRHOID STAPLER 4.8MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N2E0164UMX

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other