BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HAMONIC SCALPEL CURVED SHEARS (LCS) - PISTON GRIP 36 CM - 15 MM ACTI

    MDR report key: 1519035 · Received October 28, 2009

    Report

    Report Number
    3005075853-2009-06474
    Event Type
    Injury
    Date Received
    October 28, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 19, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 10/28/2009. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY PROCEDURE, THERE WERE SEVERAL PROBLEMS WITH THE SURGERY. FIRST THEY WERE USING A GEN01 GENERATOR BUT IT WAS NOT CUTTING PROPERLY, IT DID NOT WORK WITH THE FULL BUTTON OF THE PEDAL. SO THEY USED A GEN04 GENERATOR FOR THE SURGERY AND OPENED THE DEVICE, BUT THE SCISSOR MECHANISM DIDN'T WORK. THE SHEARS DIDN'T OPEN OR CLOSE. THE SURGEON CONVERTED THE SURGERY TO AN OPEN PROCEDURE. ADD'L INFO REQUESTED. PRERUN TESTING MUST BE PERFORMED BEFORE THE SYSTEM WILL WORK. IF PRE-RUN TESTING IS NOT DONE, THE SCREEN WILL STATE "TEST IN PROGRESS" AND THE GENERATOR WILL EMIT A DIFFERENT SOUNDING BEEP THAN WHEN IT IS ACTUALLY ACTIVATING. IF THE TIP OF THE DEVICE IS ON TISSUE, WHEN THIS OCCUR, THE SYSTEM WILL RESULT IN AN ERROR AS A RESULT OF NOT RUNNING PRE-RUN TESTING. THE "TEST" BUTTON ON THE FRONT OF THE DISPLAY IS NOT THE PRE-RUN TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HAMONIC SCALPEL CURVED SHEARS (LCS) - PISTON GRIP 36 CM - 15 MM ACTI GEI ELECTROSURGICAL, CUTTING & COAGULATION & GEI ETHICON ENDO-SURGERY, LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR| FOOTSWITCH| HANDPIECE