BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENSEAL TRIO

    MDR report key: 1006875 · Received February 28, 2008

    Report

    Report Number
    3004158985-2008-00001
    Event Type
    Other
    Date Received
    February 28, 2008
    Date of Event
    January 29, 2008
    Report Date
    February 19, 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

    EVAL SUMMARY: THE DEVICE WAS TESTED FOR PERFORMANCE AND PASSED SPEC REQUIREMENTS. VISUAL INSPECTION DID NOT SHOW DAMAGE. CONCLUSION: NO PROBLEM FOUND - DEVICE FUNCTIONS AS INTENDED. WARNINGS IN THE INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING: DO NOT ACTUATE CUTTING BLADE UNLESS TRANSECTION IS DESIRED. THIS INSTRUMENT CONTAINS A SURGICALLY SHARP EDGE. THIS DEVICE CUTS! IN ADDITION, THE IFU STATES: ENSURE THAT THE JAWS ARE ONLY IN CONTACT WITH THE TISSUE TO BE COAGULATED.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HEMICOLECTOMY THE SURGEON USED THE DEVICE TO DIVIDE ONE OF THE LATERAL ATTACHMENTS ADJACENT TO THE BOWEL. THE SURGEON REPORTED THAT THE BLADE CUT THE BOWEL DURING USE OF THE INSTRUMENT. A SMALL BOWEL PERFORATION WAS IMMEDIATELY CLOSED WITH SUTURES. NO ADDITIONAL INCISIONS OR FURTHER MODIFICATION TO THE SURGICAL PROCEDURE WERE REQUIRED. THE PT HAD AN UNEVENTFUL RECOVERY AND WAS DISCHARGED FROM THE HOSP PER SCHEDULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO ELECTROSURGICAL CUT/COAG INSTRUMENT GEI SURGRX, INC. ETRIO-335H F07L30-01

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention