BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT

    MDR report key: 1821133 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05267
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 30, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ACTIVE PIECE OF THE DEVICE BROKE DURING THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) - PISTOL GRIP 36 CM - 15 MM ACT GEI ETHICON ENDO SURGERY, INC (CINCINNATI) NA D4GT8R

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR| HANDPIECE