BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS SYNERGY CURVED BLADE

    MDR report key: 1584448 · Received January 25, 2010

    Report

    Report Number
    3005075853-2010-00294
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    December 8, 2009
    Report Date
    December 16, 2009
    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
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (A, B, C, D, E, F, G, H, I, J, L, M, N, O, P, R, S, T, U, V, W) WAS RETURNED WITH THE BLADE SCRATCHED AND CRACKED. DURING FUNCTIONAL TESTING, AN ERROR CODE 5 WAS DISPLAYED AND THE BLADE TIP FURTHER CRACKED. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 OR A SOLID TONE ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. A POSSIBLE CAUSE OF AN ERROR CODE 5 (INSTRUMENT ERROR) IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. THE DEVICE (K, Q) WAS RETURNED WITH THE DISTAL TIP OF THE BLADE BROKEN OFF AND MISSING. THE REMAINING BLADE PORTION WAS SCRATCHED. THIS BLADE TIP PORTION MAY HAVE BROKEN OFF OF THE DEVICE DURING TRANSPORT TO OUR ANALYSIS SITE. THE REPORTED COMPLAINT WAS FOR AN ERROR TONE. A POSSIBLE CAUSE OF AN ERROR TONE IS BLADE DAMAGE. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. THE DEVICE WILL STOP ACTIVATING, AND EITHER EMIT A SOLID TONE OR DISPLAY AN INSTRUMENT ERROR CODE 5 OR A SOLID TONE ON THE GENERATOR DISPLAY WHEN THE BLADE BECOMES DAMAGED. WHEN A BLADE HAS BEEN COMPROMISED SUCH AS SCRATCHED OR CRACKED, THE TITANIUM METAL IS FATIGUED WHEN CONTINUALLY ENERGIZED AND THIS RESULTS IN THE BLADE FURTHER CRACKING AND POSSIBLY BREAKING OFF. BLADE DAMAGE MAY OCCUR FROM EXTERNAL CONTACT WITH METAL OR PLASTIC DURING PRE-OP OR GENERAL USE. EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED PRIOR TO SHIPMENT, AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED AT THIS PROCESS. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS. DEVICES B, H, Q BATCH F9GJ7Y, MFG DATE 4-23-09, EXP DATE 3-23-14. DEVICE I BATCH F9GZ80, MFG DATE 6-26-09, EXP DATE 5-26-14. DEVICES D, J, K, M, P BATCH F9GL64, MFG DATE 5-4-09, EXP DATE 4-4-14. DEVICES A, E, L,V BATCH F9H83G, MFG DATE 8-10-09, EXP DATE 7-10-14. DEVICES C, N, R BATCH F9H57W, MFG DATE 7-28-09, EXP DATE 6-28-14. DEVICE S, W BATCH F9GU61, MFG DATE 6-2-09, EXP DATE 5-2-14. DEVICES F, T BATCH F9GK4U, MFG DATE 4-27-09, EXP DATE 3-27-14. DEVICE U BATCH F9GZ80, MFG DATE 6-26-09, EXP DATE 5-26-14. DEVICE G BATCH F9G56W, MFG DATE 2-24-09, EXP DATE 1-24-14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BLADES WERE QUICKLY DISFUNCTIONED WITHOUT GENERATING AN ERROR CODE. USUALLY IT IS DEFECTED THAT THE BLADE IS OUT OF ORDER BECAUSE OF 'A CONTINOUS' WOW TONE WHILE ACTIVATING THE BLADE. THE SURGEON DOES NOT TOUCH METAL OR BONE WITH BLADE. IT IS UNKNOWN WHEN PROCEDURE TOOK PLACE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. TWENTY DEVICES WILL BE RETURNING. CUSTOMER CONTACTED TO INQUIRE IF ALL THE BLADES WERE USED IN THE SAME PROCEDURE/SAME PATIENT - NO INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS SYNERGY CURVED BLADE INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. UNK F4PD3R

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR AND HANDPIECE