BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION SURG DEV, CURVED SHEARS, ENDO

    MDR report key: 738134 · Received July 14, 2006

    Report

    Report Number
    1527736-2006-03295
    Event Type
    Malfunction
    Date Received
    July 14, 2006
    Report Date
    June 23, 2006
    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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    458246-0. DATE SENT: 07/14/2006.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, THE ACTIVE BLADE WAS BROKEN, AND FELL INTO THE PATIENT. THE BLADE WAS REMOVED WITH FORCEP THROUGH THE TROCAR. A NEW INSTRUMENT WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION SURG DEV, CURVED SHEARS, ENDO GEI GEI ETHICON ENDO SURGERY, INC. (CINCINNATI) NA V9349Y

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN HAND PIECE| GENERATOR