BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM LED SURGICAL LIGHT

    MDR report key: 2481271 · Received February 22, 2012

    Report

    Report Number
    2031963-2012-00017
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    PMA / PMN Number
    K060802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. EVAL SUMMARY - THE LIGHT HEAD WAS RETURNED TO THE MFR FOR EVAL. DURING EVAL, IT WAS OBSERVED THAT THE VARISTOR COMPONENT ON THE PCB BOARD BECAME OVERHEATED CAUSING BURNING ON THE CIRCUIT BOARD. 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)(4): IT WAS REPORTED THAT THE GLASS OF THE SURGICAL LIGHT HAD SMOKE BURN MARKS IN IT AND HALF OF THE LIGHT WILL NOT TURN ON. THERE WAS NO PT INVOLVEMENT REPORTED AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1