BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35KHZ ULTRAFINE MICROTIP FOR USE WITH SELECTOR

    MDR report key: 376194 · Received February 8, 2002

    Report

    Report Number
    8010219-2002-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2002
    Report Date
    February 8, 2002
    Manufacturer
    SPEMBLY MEDICAL LTD.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT POST FOSSA CRANIOTOMY FOR EXCISION OF SPACE OCCUPYING LESION. THE END OF SELECTOR ULTRASONIC ASPIRATOR WAS FOUND TO BE MISSING AND POSSIBLE IN THE PT. THE BROKEN PIECE WAS FOUND ASPIRATED INTO THE SUCTION MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35KHZ ULTRAFINE MICROTIP FOR USE WITH SELECTOR ULTRASONIC SURGICAL ASPIRATOR LFL SPEMBLY MEDICAL LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention