BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSEAL RF60 GENERATOR W/ACCESS

    MDR report key: 1933723 · Received December 21, 2010

    Report

    Report Number
    3005075853-2010-07281
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    December 9, 2010
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED. THE UNIT WAS RECEIVED WITH MINOR SCRATCHES. THE UNIT WAS FUNCTIONALLY TESTED FOR SEVERAL DAYS AND FOUND TO BE CONFORMING TO ALL SPECIFICATIONS. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND THE UNIT HAS PASSED ALL QA INSPECTIONS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE GENERATOR WASN'T SEALING THE TISSUE DURING A CASE. NO OTHER INFORMATION IS KNOWN. NO PATIENT CONSEQUENCE OCCURRED. PATIENT INFORMATION WAS REQUESTED BUT NONE WAS AVAILABLE. FACILITY BIOMED ADVISED THAT OUTPUT WAS LOW.

    Description of Event or Problem · 1

    AFTER DISCUSSION WITH THE SURGEON, THIS INCIDENT WAS NOT A HEMOSTASIS ISSUE BUT AN ISSUE OF NO ACTIVATION WITH THE LEVER TRIGGER WAS DEPRESSED. THERE WAS NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL RF60 GENERATOR W/ACCESS GENERATOR GEI ETHICON ENDO-SURGERY, LLC. UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 DISPOSABLE