BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 2281272 · Received September 30, 2011

    Report

    Report Number
    1220685-2011-00004
    Event Type
    Other
    Date Received
    September 30, 2011
    Date of Event
    September 26, 2011
    Report Date
    September 28, 2011
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BERCHTOLD REP VISITED THE SITE ON (B)(4) 2011. IT WAS REPORTED TO HIM THAT THE LAMPHEAD DETACHED FROM THE SPRING ARM, FELL AND STRUCK A SURGICAL TEAM MEMBER IN THE HEAD AND ARM. THE LOCKING KEY THAT KEEPS THE LAMPHEAD SECURED TO THE SPRING ARM WAS FOUND ON THE FLOOR. THE LOCKING KEY COVER WAS INTACT ON THE SPRING ARM, BUT THE SCREW THAT KEEPS THE COVER IN PLACE OVER THE KEY WAS NOT FOUND. THE (B)(4) REP REINSTALLED THE LOCKING KEY, SLID THE COVER OVER IT, AND INSTALLED A NEW SCREW. THE LAMPHEAD WAS VERIFIED TO BE SECURE AND PROPERLY FUNCTIONING. BERCHTOLD COULD NOT DETERMINE WHY THE SCREW WAS MISSING.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE LAMPHEAD DETACHED FROM THE SPRINGARM AND STRUCK A MEMBER OF THE SURGICAL TEAM, BRUISING HIS HEAD AND LEG. AFTER EXAMINATION, THE SURGICAL TEAM MEMBER WAS RELEASED BACK TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL LIGHT FSY BERCHTOLD CORP. E 668

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other