BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEKSELL SELECTOR ULTRASONIC ASPIRATOR

    MDR report key: 34196 · Received July 1, 1996

    Report

    Report Number
    1037831-1996-00006
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    June 27, 1996
    Report Date
    July 1, 1996
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Product Code
    MGI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP OF A HANDPIECE (24 KHZ NEURO SHORT) BROKE OFF. THE SURGEON WAS PERFORMING A "RE-DO" BRAIN TUMOR WITH THE POWER SETTING ON THE CONSOLE AT 90%. THE HANDPIECE WAS VIBRATING AS EXPECTED, WHEN APPROX 1" OF THE TIP BROKE OFF. THE SURGEON RETRIEVED THE BROKEN TIP AND FINISHED THE SURGERY WITH THE LONG NEURO HANDPIECE WITH NO FURTHER INCIDENT. NO HARM TO THE PT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL SELECTOR ULTRASONIC ASPIRATOR ULTRASONIC ASPIRATOR MGI ELEKTA INSTRUMENTS, INC. 24 KHZ NEURO SHORT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention