BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1121910 · Received August 13, 2008

    Report

    Report Number
    3005075853-2008-01166
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Report Date
    June 26, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 8/13/2008. EVALUATION SUMMARY: THE HAND PIECE WAS TESTED ON A GENERATOR AND NO ERROR CODE WAS NOTED. HOWEVER, THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR WAS FOUND IN THE INSTRUMENT. DUE TO THIS CONDITION, IT MAY CAUSE AN ERROR CODE TO OCCUR ON THE GENERATOR. 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

    THE DEVICE WAS RECEIVED WITH NO INFO.

    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