BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 6657611 · Received June 21, 2017

    Report

    Report Number
    9710055-2017-00044
    Event Type
    Malfunction
    Date Received
    June 21, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 24, 2018
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT X¿TEN DEVICE. IT WAS STATED THAT A RUBBER GASKET LOCATED AT LIGHT HEAD ON THE DEVICE FELL OFF. NO PATIENT INVOLVEMENT OR HARM REPORTED. THERE WAS NO INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT PROVIDED SO FAR. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT-HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THIS IS A SINGLE, ISOLATED CASE AND THAT THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE. THE MANUFACTURER HAS PERFORMED AN INVESTIGATION FOR THAT CASE. ACCORDING TO THE RESULTS OF THE INVESTIGATION THE ROOT CAUSE IS AN ABNORMAL USE OF THE DEVICE AS THE SEAL CANNOT COME OFF BY ITSELF DURING INTENDED USE. A DEFECT ON THIS PART IS VISUALLY DETECTABLE DURING THE DAILY INSPECTION PERFORMED BY USERS. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION IN THE IFU WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THIS COMPLAINT IS CONSIDERED TO BE A SINGLE, ISOLATED EVENT WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    ON THE (B)(6) 2017 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH XTEN SURGICAL LIGHT. IT WAS STATED THAT THE RUBBER GASKET HAS FALLEN OFF. NO PATIENT INVOLVEMENT OR HARM REPORTED. THERE WAS NO INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT PROVIDED SO FAR. THE ISSUE IS BEING INVESTIGATED. MANUFACTURER REFERENCE NUMBER:(B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439711 XTEN LIGHT, SURGICAL, CEILING MOUNTED FSY

    Patients

    Seq Age Sex Outcome Treatment
    1