BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACKAGE, VISUM LED 2 SURGICAL LIGHT

    MDR report key: 3052059 · Received April 11, 2013

    Report

    Report Number
    0002031963-2013-00022
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INITIALLY REPORTED THAT THE CEILING-MOUNTED SURGICAL LIGHTS WERE TOO LOW AND THAT A NURSE BUMPED HIS HEAD ON THE LIGHTS. THROUGH INVESTIGATION IT WAS DISCOVERED THAT THE NURSE, WHO WAS (B)(6), ALLEGEDLY RECEIVED A SERIOUS INJURY RESULTING FROM STRIKING HIS HEAD ON THE SURGICAL LIGHT. THIS ALLEGEDLY TOOK PLACE DURING A SURGICAL PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT AND THE SURGERY HAD NO COMPLICATIONS AS A RESULT OF THE REPORTED EVENT. IT WAS ADDITIONALLY REPORTED THAT AT THE TIME OF THE EVENT, THE NURSE DID NOT LOSE CONSCIOUSNESS. AFTER A DAY OR TWO AFTER THE EVENT, THE NURSE WAS ALLEGEDLY BEHAVING DIFFERENTLY AND WAS RECOMMENDED TO HAVE A CAT SCAN. THE RESULTS OF THE CAT SCAN ALLEGEDLY SHOWED BLEEDING NEAR THE BRAIN. THE NURSE WAS AIR-LIFTED TO ANOTHER HOSPITAL WHERE SURGERY WAS PERFORMED. THE NURSE REPORTEDLY CONTINUES TO BE OFF OF WORK WHILE RECOVERING FROM THE SURGERY. ADDITIONAL INFORMATION AND DETAILS REGARDING THE EVENT AND THE CONDITION OF THE NURSE WERE REQUESTED FROM THE HOSPITAL, BUT THE HOSPITAL DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION. THROUGH INVESTIGATION, IT WAS DISCOVERED THAT WHEN THE CEILING-MOUNTED LIGHTS WERE INSTALLED, THE HOSPITAL PROVIDED INCORRECT MEASUREMENTS REGARDING THE HEIGHT OF THE CEILING WHICH RESULTED IN THE LIGHTS HANGING LOWER THAN DESIRED. THERE WAS NO MALFUNCTION OF THE LIGHTS, AND THE LIGHTS THAT WERE PROVIDED WERE TO THE CORRECT SPECIFICATIONS BASED ON THE MEASUREMENTS PROVIDED FOR THE CEILING HEIGHT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE CEILING-MOUNTED SURGICAL LIGHTS WERE TOO LOW AND THAT A NURSE BUMPED HIS HEAD ON THE LIGHTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155333 PACKAGE, VISUM LED 2 SURGICAL LIGHT VISUM LED SURGICAL LIGHT FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization