BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMOPHARE

    MDR report key: 2736898 · Received August 30, 2012

    Report

    Report Number
    1220685-2012-00004
    Event Type
    Malfunction
    Date Received
    August 30, 2012
    Date of Event
    July 22, 2012
    Report Date
    August 21, 2012
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT WAS EVALUATED BY A BERCHTOLD CORP. SERVICE TECHNICIAN ON (B)(4) 2012 AT THE LOCATION WHERE THE INCIDENT OCCURRED. THE SPINDLE THAT SECURES THE HANDLE TO THE FOCUS MECHANISM WAS FOUND TO BE BROKEN IN HALF AT THE POINT WHERE THE SET SCREW TO LOCK THE HANDLE IN PLACE IS INSERTED. THE SPINDLE WAS REPLACED AND THE LIGHT PLACED BACK INTO SERVICE. THE BROKEN SPINDLE WAS RETURNED FOR FURTHER ANALYSIS.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE FOCUS MECHANISM HANDLE FELL FROM THE SURGICAL LIGHT ONTO THE PATIENT. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL LIGHT FSY BERCHTOLD CORP. E805

    Patients

    Seq Age Sex Outcome Treatment
    1