BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1160697 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01554
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 4, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS WAS PERFORMED AND WAS FOUND THAT THE HAND PIECE NO LONGER MEETS THE SPECIFICATIONS FOR IMPEDANCE. THE HAND PIECE WAS TESTED WITH A GENERATOR AND FOUND TO BE FUNCTIONAL. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR WAS FOUND. DUE TO THIS CONDITION, IT MAY LEAD FOR TEMPERATURE ISSUES TO OCCUR. IMPEDANCE: CAUSES THAT MAY CONTRIBUTE TO THIS ARE END OF INSTRUMENT LIFE, DROPPING OF INSTRUMENT, DAMAGE TO INSTRUMENT STUD OR MOUNT, OR IMPROPER STERILIZATION. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HAND PIECE BECAME TOO HOT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE LFL ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR