BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138)

    MDR report key: 3928500 · Received June 9, 2014

    Report

    Report Number
    3004608878-2014-00067
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 14, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    NBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ENDOSCOPIC GASTROC RELEASE SYSTEM BLADE GOT STUCK AND WOULD NOT RETRACT DURING SURGERY. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE TO THE PATIENT OR USER REPORTED. THE DEVICE WAS DISCARDED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335015 ENDOSCOPIC GASTROC RELEASE SYSTEM (EGR138) ENDOSCOPIC GASTROC RELEASE NBH INTEGRA LIFESCIENCES CORPORATION OH/USA PA0016

    Patients

    Seq Age Sex Outcome Treatment
    1