BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED, SURGICAL LIGHT, NON-CAMERA READY

    MDR report key: 2181136 · Received July 8, 2011

    Report

    Report Number
    2031963-2011-00061
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA IS AVAILABLE. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE OCCUPATION OF THE INITIAL WAS NOT KNOW AT THE TIME OF THIS REPORT. DEVICE MANUFACTURE DATE WAS UNK AT THE TIME OF THIS REPORT. EVAL SUMMARY: IT WAS REPORTED THAT NON-CAMERA READY, LIGHT 2, WOULD NOT TURN ON FROM WALL CONTROL. THE ACCOUNT RESET PSB AND SWAPPED CABLING. AFTER SWAPPING CABLING AND ATTEMPTING TO TURN ON LIGHT, LIGHT BEGAN TO SMOKE. LIGHT HEAD FILLED WITH SMOKE, WHICH THEN CAME OUT OF THE LIGHT HANDLE. THE LIGHT HEAD WAS RETURNED TO STRYKER AND INSPECTED. UPON OPENING THE BOX FOR THE LIGHT HEAD, AN OBVIOUS AROMA OF BURNED ELECTRONICS WAS APPARENT. THIS IS THE FIRST SIGN OF A VARISTOR FAILURE. THE VARISTOR COMPONENT ON THIS PARTICULAR PART BECAME OVERHEATED WHICH THEN CAUSED THE CIRCUIT BOARD TO BURN. THERE ARE TWO CIRCUIT BOARDS, BOTH THE CIRCUIT BOARDS WERE AFFECTED AND THE LIGHT WENT OFF. IT APPEARS THAT THE TERMINAL BLOCK ON THE MASTER MOTHERBOARD FAILED AND SHORTED INTERNALLY. FAILURE ANALYSIS REVEALED THAT AN ASSEMBLY ERROR CREATED A HIGH RESISTANCE PATH FOR THE INPUT POWER ON THE SLAVE MOTHERBOARD. THIS PATH CREATED HEAT WHICH CAUSED THE POWER HEADER TO BREAKDOWN AND SHORT TO GROUND. THERE WAS NO REPORT OF PT INJURY OR ADVERSE CONSEQUENCES IN THIS EVENT. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(6) BEGIN CALLED IN OPERATING ROOM 12 DUAL LED SUSPENSION: NON-CAMERA READY, LIGHT 2, WOULD NOT TURN ON FROM WALL CONTROL. ACCOUNT RESET PSB AND SWAPPED CABLING. AFTER SWAPPING CABLING AND ATTEMPTING TO TURN ON LIGHT, LIGHT BEGAN TO SMOKE. LIGHT HEAD FILLED WITH SMOKE, WHICH THEN CAME OUT OF THE LIGHT HANDLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK