BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1830386 · Received January 11, 2008

    Report

    Report Number
    1527736-2008-00234
    Event Type
    Malfunction
    Date Received
    January 11, 2008
    Date of Event
    December 14, 2007
    Report Date
    December 18, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC. (CINCINNATI)
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE HAND PIECE WAS RETURNED WITH A LOOSE MOUNT AND THE NOSE CONE CRACKED. THE HAND PIECE WAS DISASSEMBLED, A COLLAPSED/TORN ACOUSTIC ISOLATOR AND EVIDENCE OF MOISTURE INGRESS WERE FOUND IN THE INSTRUMENT. THIS COULD HAVE BEEN THE CAUSE OF HOT HAND PIECE. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS THE HANDPIECE IS GETTING HOT TO THE TOUCH. THE CUSTOMER REPLACED THE DEVICE AND COMPLETED THE CASE 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, INC. (CINCINNATI) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR