BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGHT INSTRUMENTS, INC.

    MDR report key: 1961435 · Received December 22, 2010

    Report

    Report Number
    1052234-2010-00002
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 16, 2010
    Report Date
    December 22, 2010
    Manufacturer
    INSIGHT INSTRUMENTS, INC.
    Product Code
    EPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A COMBINED VITRECTOMY, THE SHEATH OF THE TORPEDO MINI LIGHT (11007.000) BEGAN TO SMOKE AND DEFORMED WHILST IN THE EYE FOR APPROXIMATELY 15 MINUTES AT 100% POWER. THE SURGEON HALTED USE WITH THE LIGHT GUIDE AND PROCEEDED WITH THE SURGERY AS NORMAL. THE SURGEON STATED THAT THERE WAS NO PT HARM OR SIGNIFICANT CHANGE IN PROCEDURE, DURATION, OR TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGHT INSTRUMENTS, INC. MLS TORPEDO MINI-LIGHT EPT INSIGHT INSTRUMENTS, INC. 11007.000 M47425

    Patients

    Seq Age Sex Outcome Treatment
    1