BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX

    MDR report key: 6889821 · Received September 25, 2017

    Report

    Report Number
    9710055-2017-00061
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    August 30, 2017
    Report Date
    January 16, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT HANAULUX 3000 DEVICE. IT WAS STATED THAT THE WELD PART OF THE LIGHT-HEAD WAS BROKEN AND CUPOLA WAS HANGING ON ONLY ONE WIRE. THERE WAS NO PATIENT INVOLVED. IT WAS ESTABLISHED THAT WHEN THE ISSUE OCCURRED, THE LIGHT HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE COMPLAINT. IN THE TIME WHEN THE ISSUE OCCURRED THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED MALFUNCTION HAS NEVER ¿TO DATE- LED TO SERIOUS INJURY OR WORSE. IT WAS FOUND THAT THE WELD AT THE FRONT PIVOT OF SPRING ARM IS BROKEN. THE BREAKAGE APPEARS TO HAVE BEEN CAUSED BY A TEARING OF THE SPRING ARM TUBE ON THE EDGE OF THE WELDING JOINT. THE SPRING ARM USED IN THE DEVICE IS OF PRODUCTION YEAR 2006. THE SPRING ARM DESIGN WAS ADAPTED BY INCREASING THE THICKNESS OF THE TUBE FROM 2006 PRODUCTION ONWARDS. THE OLD VERSION OF THE TUBE HAS 1,35 MM OF THICKNESS, WHEREAS THE NEW VERSION OF TUBE HAS 2,35 MM. AS A RESULT, THE EXTERNAL DIAMETER OF TUBE HAS INCREASED TO 34 MM. TO PREVENT ANY OTHER SIMILAR INCIDENT WE HAVE ADDRESSED THIS ISSUE WITH A PREVIOUS FIELD ACTION MSA-2009-003-IU [FDA REFERENCES Z-0182/188-2010] AND SINCE WE SEE RECURRENCE OF THE EVENTS - AS WE RECEIVED NEW COMPLAINTS FROM CERTAIN MARKETS WHERE THESE DEVICES ARE STILL IN USE- WE RECENTLY STARTED A NEW FIELD ACTION MSA-2017-002-IU IN THOSE MARKETS. WE DO NOT BELIEVE THIS TYPE OF DEVICE IS CURRENTLY IN USE IN THE US MARKET AND ALSO NO RECENT RELATED COMPLAINTS HAVE BEEN RECEIVED FOR THE US MARKET. ALTHOUGH THE OUTCOME DOES NOT SUGGEST HARM OCCURRED AT THIS TIME, WE BELIEVE IT MAY DO SO UPON RECURRENCE AND THEREFORE WE BELIEVE THIS EVENT IS IN LINE WITH A REPORTABLE ADVERSE EVENT. FURTHERMORE, WE DECIDED TO REPORT THIS EVENT AS DEVICES WITH SIMILAR SPRING ARMS WERE MARKETED IN US, EVEN ALTHOUGH THESE DEVICES ARE CONSIDERED TO BE OUT OF SERVICE. THE MANUFACTURER HAS DECIDED TO PERFORM A NEW FIELD ACTION IN JAPAN SINCE IN THAT MARKET IT IS BELIEVED AT LEAST SOME HANAULUX DEVICES ARE STILL IN USE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WILL BE INVESTIGATED BY THE MANUFACTURING SITE.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    ON 30TH OF AUGUST, 2017 MAQUET (B)(64B ECAME AWARE OF INCIDENT WITH ONE OF SURGICAL LIGHTS- HANAULUX 3000. AS IT WAS STATED, THE WELD PART OF ACROBAT 2000 SPRING ARM BROKE AND THE LIGHT-HEAD WAS HANGING ON ONLY ONE WIRE. CUSTOMER NOTICED THE EFFICIENCY WITH THE DEVICE BEFORE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670749 HANAULUX LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1