BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1171536 · Received September 18, 2008

    Report

    Report Number
    3005075853-2008-01776
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 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

    DATE SENT: 09/18/2008. EVAL SUMMARY - THE HAND PIECE WAS RECEIVED WITH A LOOSE MOUNT. THE HAND PIECE WAS RETURNED AND WAS TESTED ON A GENERATOR AND GAVE AN ERROR CODE 5. IT NO LONGER MEETS THE SPECIFICATIONS FOR CONTINUITY. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND MOISTURE INGRESS WERE FOUND. DUE TO THIS CONDITION, IT MAY LEAD FOR AN ERROR CODE 4 TO OCCUR. /CONTINUITY: CAUSES THAT MAY CONTRIBUTE TO THIS ARE PINCHED WIRES DURING MANUFACTURING, POOR SOLDERING OF WIRES IN CABLE ASSEMBLY, DROPPING OF INSTRUMENT, EXCESSIVE BENDING AND TWISTING OF CABLE AND/OR CONNECTOR, OR END OF INSTRUMENT LIFE. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HANDPIECE GAVE AN ERROR CODE 4. BIOMED DOESN'T KNOW HOW THEY HAVE FINISH THE PROCEDURE. 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