BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSORB

    MDR report key: 6431675 · Received March 24, 2017

    Report

    Report Number
    6431675
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    March 6, 2017
    Report Date
    March 8, 2017
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL STAPLER WOULD NOT RELEASE. THE EVENT IS DOCUMENTED AS "EVENT REACHED THE PATIENT BUT CAUSED NO HARM AND NO INTERVENTION OR MONITORING WAS REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215114 INSORB STAPLE, IMPLANTABLE GAG INCISIVE SURGICAL, INC. 2030 160301

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR