BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PURSTRING 65 INSTRUMENT

    MDR report key: 3170469 · Received May 24, 2013

    Report

    Report Number
    2647580-2013-00295
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Report Date
    May 1, 2013
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GDW
    PMA / PMN Number
    K901107
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INCIDENT TYPE: COLOSTOMY. ACCORDING TO THE REPORTER: PURSESTRING WAS DEPLOYED, DR (B)(6)TYING PURSE STRING, SUTURE BROKE. ANOTHER PURSESTRING WAS OPENED, AND THE CASE WAS COMPLETED. THERE WAS NO BLEEDING REPORTED IN EXCESS OF 500CC. THE CASE WAS NOT EXTENDED BY MORE THAN 30 MINUTES. THERE WAS NO UNANTICIPATED TISSUE LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230792 DISPOSABLE PURSTRING 65 INSTRUMENT DISPOSABLE SURGICAL STAPLING DEVICE GDW COVIDIEN, FORMERLY USSC PUERTO RICO P3A0367X

    Patients

    Seq Age Sex Outcome Treatment
    1