BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 131566 · Received July 8, 1997

    Report

    Report Number
    MW4002041
    Event Type
    Injury
    Date Received
    July 8, 1997
    Date of Event
    May 15, 1997
    Report Date
    May 22, 1997
    Manufacturer
    PELTON & CRANE CO.
    Product Code
    EAZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 15 MAY 1997, THE LIGHT'S HEAD AND ARM ASSEMBLY FELL OFF THE VERTICAL COLUMN, STRIKING A PT IN THE HEAD. THE PT SUSTAINED A MINOR INJURY, ALTHOUGH THE POTENTIAL FOR SERIOUS INJURY WAS PRESENT. INVESTIGATION REVEALED THAT THE SET SCREW SECURING THE ARM MOUNTING COLLAR TO THE COLUMN HAD LOOSENED ALLOWING ROTATION OF THE ENTIRE ARM UNTIL IT UNTHREADED FROM THE COLUMN AND FELL. INSTALLATION INSTRUCTIONS DO NOT INDICATE PLACEMENT OF SET SCREW OTHER THAN THAT THE VERTICAL COLUMN THREADS DO NOT SHOW. THEREFORE PLACEMENT OF SET SCREW ON WIDEST PART OF COLUMN IS POSSIBLE. IF CARE IS TAKEN TO ENSURE SET SCREW IS PLACED IN SPACE BETWEEN THE WIDE PART OF COLUMN AND THREADS THERE WILL BE LESS POTENTIAL FOR ACCIDENTS. ADDITIONALLY, PREVENTIVE MAINTENANCE PROCEDURES SHOULD INCLUDE ROTATION LIMITS OF ARM AND TIGHTNESS OF SET SCREW. MFR DATE IS 11/82.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI LIGHT, DENTAL OPERATING, CEILING MOUNTED EAZ PELTON & CRANE CO. LFT II NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO