BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENSEAL TRIO W/ RF-60

    MDR report key: 1067894 · Received June 28, 2008

    Report

    Report Number
    3004158985-2008-00002
    Event Type
    Other
    Date Received
    June 28, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 28, 2008
    Manufacturer
    SURGRX, INC.
    Product Code
    GEI
    PMA / PMN Number
    K072493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DISPOSABLE UNIT: THE DISPOSABLE DEVICE WAS TESTED FOR PERFORMANCE AND PASSED SPECIFICATION REQUIREMENTS. VISUAL INSPECTION DID NOT SHOW DAMAGE. GENERATOR: THE ELECTROSURGICAL GENERATOR WAS ALSO RETURNED FOR EVALUATION. IT WAS NOTED THAT THE GENERATOR HAD A SIGNIFICANT DENT IN THE COVER, THE SCREWS WERE STRIPPED THAT HOLD THE COVER IN PLACE, AND THE COVER WAS LOOSE. THERE WERE ALSO LOOSE PARTICLES OR COMPONENT PIECES INSIDE THE GENERATOR. THIS DAMAGE APPEARED TO BE THE RESULT OF SEVERE IMPACT TO THE GENERATOR. APPARENTLY AS A RESULT OF THE IMPACT DAMAGE TO THE GENERATOR, THE GENERATOR DELIVERED POWER ONLY INTERMITTENTLY. CONCLUSION: ELECTROSURGICAL GENERATOR WAS DAMAGED AND AS A RESULT, WAS NOT FUNCTIONING NORMALLY. THE INSTRUCTIONS FOR USE CLEARLY STATE: EXAMINE THE GENERATOR FOR DAMAGE. DO NOT USE A DAMAGED DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP-BAND AND UNPLANNED PARAESOPHAGEAL HERNIA REPAIR, THE ENSEAL DEVICE DID NOT APPEAR TO PERFORM NORMALLY. IT WAS LATER DISCOVERED THAT A DAMAGED GENERATOR HAD BEEN USED FOR THE PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED AND THE PATIENT MOVED TO THE POST-ANESTHESIA CARE UNIT, THE PATIENT WAS RETURNED TO THE OR FOR A SECONDARY PROCEDURE TO STOP INTERNAL BLEEDING. PATIENT WAS DISCHARGED FROM HOSPITAL WITH NORMAL POST-OP LAP-BAND INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL TRIO W/ RF-60 ELECTROSURGICAL CUT/COAG INSTRUMENT GEI SURGRX, INC. ETRIO-345H F08E01-01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention