BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTOR ULTRASONIC ASPIRATOR

    MDR report key: 71807 · Received January 16, 1997

    Report

    Report Number
    71807
    Event Type
    Injury
    Date Received
    January 16, 1997
    Date of Event
    June 12, 1996
    Report Date
    August 7, 1996
    Manufacturer
    ELEKTA INSTRUMENTS, INC.
    Product Code
    LBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HANDPIECE OF THE DEVICE DID NOT OPERATE PROPERLY TO REMOVE A TUMOR NECESSITATING AN ALTERNATIVE TECHNIQUE BY THE SURGEON TO ACCOMPLISH THE TASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTOR ULTRASONIC ASPIRATOR SURGICAL ASPIRATOR LBK ELEKTA INSTRUMENTS, INC. 152200M *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Disability