BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SYNERGY* CURVED BLADE

    MDR report key: 2983353 · Received February 28, 2013

    Report

    Report Number
    3005075853-2013-00941
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K012176
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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): ADDED ADDITIONAL INFORMATION THE DEVICE WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED, NOT BROKEN OFF AS REPORTED. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED. WHEN A BLADE HAS BEEN COMPROMISED, SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. DURING THE ANALYSIS PROCESS, THE BLADE WAS TESTED FOR SCRATCHES AND CRACKS AND THE BLADE BROKE OFF. A PROBABLE CAUSE OF AN ERROR CODE 5 IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. IF THE HARMONIC SYSTEM SENSES AN INSTRUMENT FAULT DURING USE, AN AUDIBLE ALARM (TONE WITH LONG PULSES) WILL SOUND AND A VISUAL ALARM INDICATOR WILL APPEAR ON THE CONTROL PANEL. THE GENERATOR SYSTEM WILL REVERT TO STANDBY MODE, WHEN THE AUDIBLE ALARM (SOLID TONE) AND VISUAL ALARM INDICATOR APPEAR. BECAUSE THE RETURNED BLADE WAS NOT BROKEN OFF AS REPORTED, IT IS POSSIBLE THAT THE DEVICE RETURNED MAY HAVE BEEN USED TO COMPLETE THE PROCEDURE AND IS NOT THE DEVICE COMPLAINED ABOUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CONIZATION, THE BLADE WAS BROKEN OFF OUTSIDE THE PATIENT. NO PIECES FELL INTO THE PATIENT. NO ERROR CODES WERE SEEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85552 HARMONIC SYNERGY* CURVED BLADE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK H91U03

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR, HANDPIECE