BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACKAGE, VISUM LED 2 SURGICAL LIGHT

    MDR report key: 6204711 · Received December 27, 2016

    Report

    Report Number
    0008010153-2016-00108
    Event Type
    Injury
    Date Received
    December 27, 2016
    Date of Event
    December 5, 2016
    Report Date
    May 12, 2017
    Manufacturer
    STRYKER-COMMUNICATIONS
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HANDLE COVER DISENGAGED FROM THE VISUM LED 2 LIGHT. THE COVER WAS RETURNED TO STRYKER FLOWER MOUND. AFTER INVESTIGATION, IT WAS DETERMINED THAT THE O-RING, A COMPONENT OF THE VISUM LED LIGHT HANDLE ASSEMBLY, WAS MISSING AND THAT THE COVER ITSELF FUNCTIONED AS INTENDED. IT WAS ALSO CONFIRMED THAT THE HANDLE WAS VERIFIED TO BE MANUFACTURED CORRECTLY. THE VISUM LED LIGHT HANDLE O-RING FORCES THE COVER INTO POSITION SO IT CORRECTLY LATCHES. THE MISSING O-RING IS THE ROOT CAUSE OF THE FAILURE. ADDITIONALLY, WHEN THE INITIAL EMDR WAS FILED, IT WAS FILED UNDER THE REGISTRATION NUMBER OF (B)(4) AND IS CORRECTLY FILED IN THE SUPPLEMENTAL WITH THE REGISTRATION NUMBER OF (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HANDLE COVER ALLEGEDLY FELL OFF ON TO THE SURGICAL FIELD AND THE PROCEDURE WAS DISCONTINUED. THERE WAS A REPORTED CUT FOR INSERTION OF A CATHETER TO THE PATIENT AND THE INCIDENT IS BEING INVESTIGATED. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE COVER ALLEGEDLY FELL OFF ON TO THE SURGICAL FIELD AND THE PROCEDURE WAS DISCONTINUED. THERE WAS A REPORTED CUT FOR INSERTION OF A CATHETER TO THE PATIENT AND THE INCIDENT IS BEING INVESTIGATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDLE COVER ALLEGEDLY FELL OFF ON TO THE SURGICAL FIELD AND THE PROCEDURE WAS DISCONTINUED. THERE WAS A REPORTED CUT FOR INSERTION OF A CATHETER TO THE PATIENT AND THE INCIDENT IS BEING INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855280 PACKAGE, VISUM LED 2 SURGICAL LIGHT SURGICAL LIGHT FSY STRYKER-COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other