BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 3138181 · Received May 7, 2013

    Report

    Report Number
    3004028675-2013-00010
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 11, 2013
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDW
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MFR. NO INFORMATION FORTHCOMING ON CASE, PT, OR PHYSICIAN.

    Description of Event or Problem · 1

    INCISIVE SURGICAL HAS RECEIVED INFORMATION ON EVENT FROM FDA LETTER, (B)(4), STATING A STAPLER "FIRED 3 STAPLES AT ONCE." THE PROCEDURE WAS A C-SECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199989 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GDW INCISIVE SURGICAL, INC. 2030 124001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK