BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1080358 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00371
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/10/2008. EVAL SUMMARY: THE HAND PIECE WAS RETURNED WITH THE LOOSE MOUNT AND THE NOSE CONE CRACKED. IT WAS TESTED ON A GENERATOR AND GAVE AN ERROR CODE 3. FOR FURTHER ANALYSIS, THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE DEVICE WENT INTO STANDBY AND THERE IS A CRACK IN THE HOUSING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE NONE LFL ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR