BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB SKIN STAPLER

    MDR report key: 5528714 · Received March 28, 2016

    Report

    Report Number
    5528714
    Event Type
    Malfunction
    Date Received
    March 28, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 17, 2016
    Manufacturer
    INCISIVE SURGICAL, INC
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSORB STAPLER MISS-FIRED, THEN THE STAPLES WOULDN'T COME OUT. NEW STAPLER OPENED AND USED WITHOUT INCIDENT. MANUFACTURER RESPONSE FOR SUBCUTICULAR SKIN STAPLER, INSORB SUBCUTICULAR SKIN STAPLER (PER SITE REPORTER): MATERIAL MANAGEMENT WILL CONTACT SALES REP TO ARRANGE RETURN IF DESIRED BY THEIR COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185315 INSORB SKIN STAPLER SKIN STAPLER GDW INCISIVE SURGICAL, INC 155191

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR NO