BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1160689 · Received September 5, 2008

    Report

    Report Number
    3005075853-2008-01539
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 23, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND A CRACKED NOSE CODE. DEVICE WAS TESTED ON A GENERATOR AND GAVE ERROR#3. THE HAND PIECE WAS DISASSEMBLED, AND A TORN ACOUSTIC ISOLATOR, AND MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. 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 SYSTEM RESPONDS ERROR 3. ANOTHER HANDPIECE WAS USED 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