BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL TEMPERATURE CONTROLLED TISSUE SEALING TECHNOLOGY

    MDR report key: 1488156 · Received September 21, 2009

    Report

    Report Number
    1488156
    Event Type
    Malfunction
    Date Received
    September 21, 2009
    Date of Event
    September 8, 2009
    Report Date
    September 20, 2009
    Manufacturer
    SURGRX, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ENSEAL HANDPIECE OPENED FOR USE DURING SURGERY. WHILE IT WAS BEING USED ON PATIENT, IT DID NOT FINISH ITS CYCLE OF USE AND THEN IT DEFAULTED TO "REPLACE." DEVICE HAD ONLY BEEN ON THE FIELD FOR A SHORT TIME (LESS THAN 5 MINUTES) WHEN IT STOPPED WORKING. IT WAS THEN REPLACED WITH A NEW HANDPIECE.THERE WAS NO PATIENT INJURY.BIOMED DID A VISUAL INSPECTION AND SEND THE ENSEAL TEMPERATURE CONTROLLED TISSUE SEALING TECHNOLOGY TO SURGRX, INC.POWER SETTING IS UNK. ESU UNIT INFORMATION IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TEMPERATURE CONTROLLED TISSUE SEALING TECHNOLOGY HANDPIECE, TISSUE SEALING, RF GEI SURGRX, INC * F09D13-02

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR