BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM

    MDR report key: 3944157 · Received July 18, 2014

    Report

    Report Number
    3005075853-2014-05084
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A. DEVICE EVALUATION CODE 81 - NO DEVICE RECEIVED FOR ANALYSIS AT TIME OF SUBMISSION OF 3500A WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED WITH THE BLADE BURN MARKS BROKEN RETURNED DISCOLORED (BLUE) DUE TO HEAT GENERATED FROM CONTACT BETWEEN THE BLADE AND TISSUE PAD. THE DEVICE WAS FUNCTIONALLY TESTED WITH A GENERATOR. DURING FUNCTIONAL TESTING ON GEN11 INSTRUMENT ERROR SCREEN WAS RECEIVED. A PROBABLE CAUSE OF THE DEVICE STOP ACTIVATING AND DISPLAY AN INSTRUMENT ERROR ALERT SCREEN IS BLADE DAMAGE. THE BLADE WAS FOUND TO BE BROKEN AT THE DISCOLORED (BLUE). THE PORTION OF BLADE WAS INSPECTED AND IT WAS FOUND CRACKED. ONCE MINOR BLADE DAMAGE HAS OCCURRED, SUBSEQUENT ACTIVATIONS MAY INCREASE DAMAGE SEVERITY AND RESULT IN YELLOW ALERT SCREENS, SUCH AS ¿TIGHTEN ASSEMBLY¿ OR ¿BLADE ERROR DETECTED¿ FOLLOWED BY A ¿REPLACE INSTRUMENT¿ SCREEN LATER IN THE PROCEDURE, AND CONTINUED USAGE CAN RESULT IN A BROKEN BLADE. PROBABLE CAUSE OF BLADE DISCOLORATION IS APPLYING PRESSURE BETWEEN THE INSTRUMENT BLADE AND TISSUE PAD WITHOUT HAVING TISSUE BETWEEN THEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE GENERATOR EMITTED THE MESSAGE 'REPLACE HANDLE'; SUBSEQUENTLY THE ACTIVE BLADE BROKE OFF. THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW DEVICE. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422318 ULTRACISION** HARMONIC SCALPEL** CURVED SHEARS, SCISSOR-GRIP HANDLE - 14 CM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA L4E665

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE