BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENOSCOPIC GASTRO RELEASE SYSTEM (EGR138)

    MDR report key: 3240290 · Received July 18, 2013

    Report

    Report Number
    3004608878-2013-00133
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 18, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    NBH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BLADE ON THE GER SYSTEM WOULD NOT RETRACT DURING A SURGICAL PROCEDURE. THIS CAUSED THE SURGEON THE EXTEND THE INCISION IN ORDER TO REMOVE THE BLADE FROM THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334817 ENOSCOPIC GASTRO RELEASE SYSTEM (EGR138) ENDOSCOPIC GASTROC RELEASE NBH INTEGRA LIFESCIENCES CORPORATION PA007

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention