BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC SCALPEL ULTRACISION HAND PIECE

    MDR report key: 289058 · Received August 7, 2000

    Report

    Report Number
    1527736-2000-03578
    Event Type
    Malfunction
    Date Received
    August 7, 2000
    Report Date
    July 10, 2000
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    LFL
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE GENERATOR IS BEING RETURNED TO THE REPAIR FACILITY FOR THE FOLLOWING REASON: INTERMITTENTLY GIVES THE CONSTANT TONE. BIOMED HAS DONE THE DIAGNOSTIC TESTS AND CAN FIND NO PROBLEMS. THE REP STATES THIS HAPPENS INTERMITTENTLY WITH MULTIPLE BLADES AND HANDPIECES. THE REP AND CUSTOMER INSIST THIS UNIT BE SENT BACK FOR CHECKOUT. THE ACCOUNT IS REQUESTING THE FOLLOWING SHIPPING MATERIAL TO SEND THEIR UNIT BACK. SHIPPING BOX P/N 31133, QUANTITY 1; PACKAGING INSERTS, P/N 29656, QUANTITY 2; PACKAGING DIVIDER INSERT, P/N 31135, QUANTITY 1; POLY BAG P/N 17857, QUANTITY 1.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other