BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SUBCUTICULAR STAPLER

    MDR report key: 3701563 · Received February 20, 2014

    Report

    Report Number
    3004028675-2014-00001
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    December 13, 2013
    Report Date
    February 10, 2014
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GAG
    PMA / PMN Number
    K120373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT A CESAREAN SECTION AND THE INSORB 2030 SKIN STAPLER WAS USED TO CLOSE THE SKIN INCISION. THE USER EXPERIENCED A DEVICE MALFUNCTION WHILE IN THE OPERATING ROOM. THE DEVICE WAS RETURNED FOR INVESTIGATION AND A PORTION OF THE DEVICE WAS BROKEN OFF AND NOT RETURNED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107790 INSORB SUBCUTICULAR STAPLER SKIN STAPLER GAG INCISIVE SURGICAL, INC. 2030 133601

    Patients

    Seq Age Sex Outcome Treatment
    1