BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE, VISUM LED2 SURGICAL LIGHT, CAMERA READY

    MDR report key: 2141288 · Received June 1, 2011

    Report

    Report Number
    2031963-2011-00041
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE INFO IN THIS MEDWATCH WAS SUPPLIED TO STRYKER (B)(4) BY STRYKER'S (B)(4) IN (B)(4) DURING INSTALLATION. THE DEVICE WAS INSPECTED ON SITE DURING INSTALLATION. EVAL SUMMARY: IT WAS REPORTED THAT DURING INSTALLATION OF A LIGHT HEAD, IT WAS DISCOVERED THE LIGHT WAS MISSING THE CIRCLIP. THE CIRCLIP IS USED TO HOLD THE LIGHT HEAD TO THE CARDANIC. IF THE CLIP IS MISSING, THE LIGHT HEAD COULD POTENTIALLY FALL. IF THIS WERE TO OCCUR DURING A CASE, THIS COULD HAVE RESULTED IN A SERIOUS OR SEVERE ADVERSE HEALTH EVENT. THIS TYPE OF EVENT DID NOT OCCUR FOR THIS INSTANCE BUT COULD HAVE OCCURRED. A MISSING CIRCLIP ON A LIGHT HEAD COULD RESULT IN THE LIGHT FALLING. IF THIS WERE TO OCCUR DURING CASE, THIS COULD HAVE RESULTED IN A SERIOUS OR SEVERE ADVERSE HEALTH EVENT. THIS EVENT OCCURRED DURING INSTALLATION, THUS, THERE WAS NO PT INVOLVEMENT OR INJURY. THIS INCIDENT WILL HAVE AN NCR OPENED AND WILL BE MONITORED THROUGH THE NCMB PROCESS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). (B)(6) REPORTED THAT IS A LOOSE SCREW INSIDE THE LIGHT HEAD AND ALSO A MISSING CIRCLIP THAT SHOULD RETAIN THE LIGHT HEAD TO THE SUSPENSION. (B)(6) FURTHER REPORTED THAT THE INSTALLATION AT THIS ACCOUNT IS NOT YET COMPLETE BUT HE EXPECTS THE ROOM TO OPEN WITHIN THE (B)(6). NON ADVERSE CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACKAGE, VISUM LED2 SURGICAL LIGHT, CAMERA READY FSY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA