BEUDAMED
    FDA Adverse Event Injury Summary report: N

    33M HEMORRHOID STAPLER 4.8MM STAPLES

    MDR report key: 3001354 · Received March 6, 2013

    Report

    Report Number
    1219930-2013-00169
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K083781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: HEMORRHOIDECTOMY. ACCORDING TO THE REPORTER. THE MACHINE FIRED CUTTING THE TISSUE BUT THE STAPLES OPENED. THE SURGEON HAD TO HAND-SUTURE THE STAPLE LINE ON THE TOP OF THOSE THAT WERE OPENED. THE CASE WAS EXTENDED BY MORE THAN 30 MINS. THERE WAS NO UNANTICIPATED TISSUE LOSS. THERE WAS TISSUE DAMAGE AND THE PT'S HOSPITAL STAY WAS EXTENDED FOR 2 MORE DAYS. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. REINFORCEMENT MATERIAL WAS NOT USED IN CONJUNCTION WITH THE STAPLING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95471 33M HEMORRHOID STAPLER 4.8MM STAPLES DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY US SURGICAL N2M0031MX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O