BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENSEAL 5MM W/ RF-60

    MDR report key: 1278338 · Received December 23, 2008

    Report

    Report Number
    3004158985-2008-00003
    Event Type
    Other
    Date Received
    December 23, 2008
    Date of Event
    November 26, 2008
    Report Date
    November 26, 2008
    Manufacturer
    SURGRX, INC.
    Product Code
    GEI
    PMA / PMN Number
    K072177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DISPOSABLE DEVICE WAS TESTED FOR PERFORMANCE AND PASSED SPECIFICATION REQUIREMENTS. VISUAL INSPECTION DID NOT SHOW EVIDENCE OF DAMAGE. CONCLUSION: NO PROBLEM FOUND - DEVICE FUNCTIONS AS INTENDED. THE ENSEAL DEVICE PRODUCES MINIMAL THERMAL SPREAD (APPROX. 1MM) AND HAS A TEMPERATURE CONTROL FEATURE TO PREVENT TISSUES FROM REACHING EXCESSIVELY HIGH TEMPERATURES. THE SURGEON HAD HIS HAND NEXT TO INSTRUMENT DURING ACTIVATION OF THE INSTRUMENT WITH NO ADVERSE EFFECT. INSTRUCTIONS FOR USE STATE: ACTIVATE THIS DEVICE ONLY WHEN THE JAWS ARE UNDER DIRECT VISUAL OBSERVATION TO AVOID UNINTENDED TISSUE COAGULATION OR NECROSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN LOWER ANTERIOR RESECTION OF THE COLON, WHILE TAKING THE GREATER OMENTUM WITH THE DEVICE APPROX. 1CM AWAY FROM THE COLON, A LONGITUDINAL SECTION ALONG THE COLON OPENED UP AND REQUIRED INTERVENTION. THE SURGEON BELIEVES THAT THE EVENT WAS A RESULT OF THE PATIENT'S CIRRHOTIC CONDITION, AND NOT ATTRIBUTED TO THE DEVICE, AS HIS HAND WAS NOT ADVERSELY AFFECTED. PATIENT WAS DISCHARGED AFTER AN UNEVENTFUL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL 5MM W/ RF-60 ELECTROSURGICAL CUT/COAG INSTRUMENT GEI SURGRX, INC. NSEAL-525RH F08H29-01

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention