BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 11567740 · Received March 25, 2021

    Report

    Report Number
    9710055-2021-00112
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Report Date
    April 20, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH XTEN SURGICAL LIGHT. AS IT WAS STATED, PLATES FOR SPRING ARM WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT, AS THE DUST COVERS SHOULD BE ATTACHED STILL TO THE DEVICE. THERE IS NO INFORMATION PROVIDED IF IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS OR WAS NOT BEING USED FOR THE PATIENT TREATMENT. THE POSSIBLE ROOT CAUSES ARE: - NON-CONFORMITY OF THE METAL COVERS ASSEMBLY. - DEGRADATION OF THE METAL COVERS. - IMPROPER USE (COLLISION WITH ANOTHER DEVICE) MAQUET SAS ANALYSIS SHOWS THAT THE METAL STRIP COMES OUT OF THE COVERS WHEN IT IS NOT CLIPPED PROPERLY. IN THE SCOPE OF OUR CONTINUOUS IMPROVEMENT POLICY, MAQUET SAS INITIATED A MODIFICATION FILE (E131106) TO INCLUDE THIS DUST COVER FITTING PROCEDURE IN THE TECHNICAL DOCUMENTATIONS WITH ALL SPRING ARMS. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON 23RD MARCH, 2021 GETINGE BECAME AWARE OF AN ISSUE WITH XTEN SURGICAL LIGHT. AS IT WAS STATED, PLATES FOR SPRING ARM WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464835 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD567825999

    Patients

    Seq Age Sex Outcome Treatment
    1