BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB

    MDR report key: 3893503 · Received June 9, 2014

    Report

    Report Number
    3893503
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 9, 2014
    Manufacturer
    INCISIVE SURGICAL INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STAPLER FIRED THE STAPLES TO THE SIDE OF THE INCISION INSTEAD OF IN THE MIDDLE OF INCISION. ANOTHER PRODUCT OPENED & USED WITHOUT INCIDENT.======================MANUFACTURER RESPONSE FOR SUBCUTICULAR SKIN STAPLER, INSORB (PER SITE REPORTER).======================SALES REP NOTIFIED - REPORTER NOT AWARE OF RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336131 INSORB STAPLER, SURGICAL GAG INCISIVE SURGICAL INC. * 140801

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR