BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENSEAL TRIO 3MM CURVE TIP 35 C

    MDR report key: 1430740 · Received July 28, 2009

    Report

    Report Number
    3005075853-2009-04518
    Event Type
    Injury
    Date Received
    July 28, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 7, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/31/2009. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. CORRECTED DATA: (CATALOG #). USER FACILITY MEDWATCH # IS ATTACHED. EVALUATION REPORT: THE COMPLAINT COULD NOT BE CONFIRMED, BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. DEVICE NOT RETURNED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: 2009. TEMPERATURE CONTROLLED TISSUE SEALING. SURGRX, INC, CATALOG# ETRIO-335. LOT# F09A21-01. INITIAL REPORTER ALSO SENT REPORT TO FDA: NO.

    Description of Event or Problem · 1

    ADDITIONAL INFO FROM THE USER FACILITY REPORT: THE PT WAS SCHEDULED FOR A LAPAROSCOPIC CONVERTED TO OPEN SPLENECTOMY. THE ENSEAL DEVICE FAILED TO WORK WHEN PLUGGED INTO MACHINE. CODE ON THE MACHINE STATED "REPLACE". A SECOND MACHINE WAS TRIED WITH THE SAME RESULT. THE ENSEAL HANDPIECE WAS REMOVED FROM THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO 3MM CURVE TIP 35 C GEI ETHICON ENDO-SURGERY, LLC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other GENERATOR