BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHROMOPHARE

    MDR report key: 2215128 · Received August 12, 2011

    Report

    Report Number
    1220685-2011-00003
    Event Type
    Other
    Date Received
    August 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIGHT SYSTEM WAS INSTALLED IN (B)(6) IN (B)(6) IN (B)(6) 2003, AND WAS IN USE AT (B)(6) IN (B)(6)WHERE THE INCIDENT OCCURRED. A BERCHTOLD CORPORATION SERVICE REPRESENTATIVE VISITED THE SITE ON (B)(4) 2011. IT WAS REPORTED TO HIM THAT THE LIGHT FELL FROM THE SUSPENSION TUBE BECAUSE THE SCREWS THAT HOLD IT TO THE TUBE WERE LOOSE. THE BERCHTOLD SERVICE REPRESENTATIVE COULD NOT VERIFY THIS OR DETERMINE CONCLUSIVELY THAT LOOSE SCREWS WERE THE CAUSE, BECAUSE UPON ARRIVAL, THE LIGHT SYSTEM HAD BEEN REASSEMBLED. THE LIGHT SYSTEM WAS NOT MAINTAINED BY BERCHTOLD PERSONNEL. THE SYSTEM WAS INSPECTED AGAIN ON (B)(4) 2011, BY THE BERCHTOLD CORPORATION SERVICE REPRESENTATIVE AND A REPORT ISSUED TO MMIC. THE SYSTEM WAS FOUND TO BE FUNCTIONAL, ALBEIT RECOMMENDATIONS WERE MADE FOR REPAIR OF SOME MECHANICAL ITEMS AND REPLACEMENT OF WIRING HARNESSES.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE LIGHT SUSPENSION SYSTEM WAS REPORTED TO HAVE DETACHED FROM THE SUSPENSION TUBE, ALLOWING IT TO FALL AND STRIKE 2 OPERATING ROOM STAFF PERSONNEL AND THE PT. ONE OPERATING ROOM STAFF PERSON WAS REPORTED TO HAVE SUSTAINED A HEAD INJURY, AND THE SECOND A BACK INJURY. NO REPORT ON WHETHER THE PT WAS INJURED WAS RECEIVED. IDENTIFICATION OF PERSONNEL INVOLVED IN THE INCIDENT WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMOPHARE SURGICAL LIGHT FSY BERCHTOLD CORP. D 530

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other