BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1160674 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01527
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 15, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HAND PIECE WAS RECEIVED WITH A NOSE CONE CRACKED AND A LOOSE MOUNT. THE DEVICE WAS TESTED ON A GENERATOR AND NO ERROR CODE WAS NOTED. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. DUE TO THIS CONDITION, IT MAY LEAD FOR AN ERROR CODE 3 OR 5 TO OCCUR. 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 THE HANDPIECE GAVE THE ERROR CODE 3 AND 5. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCE.

    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