BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1823664 · Received November 16, 2007

    Report

    Report Number
    1527736-2007-07811
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 4, 2007
    Report Date
    October 10, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI0
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BLADDER PROCEDURE THE TISSUE PAD WAS DEFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    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 (CINCINNATI0 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 HANDPIECE| GENERATOR