BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-TEN

    MDR report key: 8738913 · Received June 27, 2019

    Report

    Report Number
    9710055-2019-00208
    Event Type
    Malfunction
    Date Received
    June 27, 2019
    Date of Event
    June 26, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    ON (B)(6)2019 MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. THE RECEIVED ALLEGATION IS STATED AS: THE SCREW FROM THE SPRING ARM IS CONSTANTLY LOOSENING AND MISSING. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO THE STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. THERE IS NO INFORMATION IF DURING THE EVENT OCCURRENCE THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. THE ROOT CAUSE IS AN INCORRECT TIGHTENING OF COVERS SIDE SCREWS DURING MAINTENANCE. THE FALL OF THE PLASTIC CAP COULD BE A DIRECT RESULT OF A LOOSENED SCREW AND A LACK OF VERIFICATION DURING ANNUAL MAINTENANCE. AS THERE IS NO INFORMATION PROVIDED WHO PERFORMS PREVENTIVE MAINTENANCE AND WE HAVE NO INFORMATION IF IT EVER WAS PERFORMED, WE CAN ASSUME THAT THE MOST LIKELY ROOT CAUSE IS LACK OF MAINTENANCE, HOWEVER IT CANNOT BE FULLY CONFIRMED. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THIS IS THE 4TH COMPLAINT OF THIS NATURE ON THIS DEVICE TYPE (DISCONTINUED) WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. H3 OTHER TEXT: DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER #222934.

    Description of Event or Problem · 0

    ON 26TH JUNE, 2019 MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- X-TEN. AS STATED, THE SCREW FROM THE SPRING ARM IS CONSTANTLY LOOSENING AND MISSING. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO THE STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER #222934.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534934 X-TEN LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1