BEUDAMED
    FDA Adverse Event Other Summary report: N

    LED SURGICAL LIGHT

    MDR report key: 1590475 · Received January 18, 2010

    Report

    Report Number
    2031963-2010-00007
    Event Type
    Other
    Date Received
    January 18, 2010
    Date of Event
    December 22, 2009
    Report Date
    December 22, 2009
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NURSE TECH'S IDENTIFIER'S HAVE NOT BEEN OFFERED. FURTHER ATTEMPTS WILL BE MADE FOR THIS INFORMATION. THIS WAS NOT A PRODUCT PROBLEM OR ADVERSE EVENT. THERE IS NO EXPIRATION DATE ESTABLISHED FOR THIS DEVICE. DEVICE WAS EVALUATED IN THE FIELD. THIS DOES NOT CONSTITUTE AS A MALFUNCTION, DEATH OR SERIOUS INJURY. DEVICE MANUFACTURED DATE IS UNKNOWN AT THIS POINT. FURTHER ATTEMPTS WILL BE MADE FOR THIS INFORMATION. EVALUATION SUMMARY - THIS TYPE OF FAILURE WAS USER MISUSE WHICH RESULTED IN THE LIGHT TURNING OFF DURING A CASE. THE DOCTOR ACCIDENTLY MOVED THE LIGHT HEAD TO A POSITION MORE DESIRABLE AND UPON DOING SO, ACCIDENTALLY HIT A NURSE IN THE HEAD. WHEN THE NURSE WAS HIT, THE LIGHT WENT OUT. THIS TYPE OF FAILURE WOULD BE CONSIDERED USER MISUSE AND IS NOT THE FAULT OF STRYKER COMMUNICATIONS. THIS IS NOT A SINGLE-USE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE DOCTOR WAS ROTATING THE LED LIGHT AND ACCIDENTALLY HIT A NURSE TECH IN THE HEAD. WHEN THE LIGHT HIT HER IN THE HEAD, THE LIGHT WENT OUT. NO ADVERSE CONSEQUENCES TO USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LED SURGICAL LIGHT FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK