BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLX 3005

    MDR report key: 6598759 · Received May 30, 2017

    Report

    Report Number
    9710055-2017-00038
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    May 4, 2017
    Report Date
    January 16, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT HANAULUX 3005 DEVICE IN (B)(6). IT WAS STATED THAT THE LIGHT HEAD ALMOST FELL DOWN DURING THE PREPARATION OF THE SURGICAL ROOM. THERE WAS NO PATIENT INVOLVED. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE LIGHT HEAD DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THE REPORTED MALFUNCTION HAS NEVER- TO DATE- LEAD TO SERIOUS INJURY OR WORSE. IT WAS REPORTED 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[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 SIMILAR DEVICES 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 (B)(6) SINCE IN THAT MARKET IT IS BELIEVED AT LEAST SOME HANAULUX DEVICES ARE STILL IN USE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED AFTER INVESTIGATION RESULT.

    Description of Event or Problem · 1

    ON THE (B)(6) MAQUET SAS BECAME AWARE OF AN MALFUNCTION OF THE HLX 3005 (PRODUCT FAMILY HANAULUX 3000) DEVICE. IT WAS REPORTED BY CUSTOMER THAT THE "LIGHT ALMOST FELL DOWN" . THE ISSUE WAS DISCOVERED DURING THE PREPARATION OF THE SURGICAL ROOM. THE HANAULUX 3000 SERIES LIGHT SYSTEM IS NOT MARKETED IN THE US. THIS REPORT HAS BEEN MADE DUE TO A SIMILARITY WITH DEVICES MARKETED BY MAQUET IN THE US. MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380481 HLX 3005 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1