BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMALIX 6401 SAL/DF/T

    MDR report key: 6555487 · Received May 9, 2017

    Report

    Report Number
    9710055-2017-00031
    Event Type
    Malfunction
    Date Received
    May 9, 2017
    Date of Event
    April 14, 2017
    Report Date
    October 16, 2017
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    MAQUET SAS BECAME AWARE OF AN INCIDENT WITH SURGICAL LIGHT PRISMALIX 6401. IT WAS STATED THAT DURING THE SURGERY, THE HEADLIGHT WAS DRIFTING AND MAY HAVE CONTACTED THE DOCTOR¿S HEAD. THE MALFUNCTION OCCURRED ON PRISMALIX 6401 WHICH IS SURGICAL LIGHT WITH EASY MOVEMENT HANDLING, ORIGINAL TREATMENT OF THE LIGHT VOLUME AND SUPERB SHADOW DILUTION. 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 BEING USED FOR AIDING PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THIS IS THE FIRST ISSUE OF THIS NATURE FOR PRISMALIX DEVICES. FURTHERMORE IT WAS FOUND BY THE MANUFACTURING SITE THAT THE EVENT OCCURRED AS A RESULT OF TWO FACTORS: DEFECTIVE SPRING ARM (BAD STRENGTH OF SPRING) AND INCORRECT ADJUSTMENT OF THE SPRING ARM. WHEN THE SPRING ARM HAS NOT ENOUGH STRENGTH TO KEEP THE COPULA IN ONE PLACE, THE DRIFTING OCCURS. ADDITIONALLY, TO MINIMIZE THE HANDLING OF THE COPULA DURING THE PROCEDURE, THE PRISMALIX INSTRUCTIONS FOR USE SHOWS HOW TO PREPOSITION THE SURGICAL LIGHT- THIS SHOULD BE PERFORMED BEFORE THE PATIENT IS BROUGHT INTO THE OPERATING THEATRE. ALSO IT PROVIDES THE INFORMATION THAT THE SAFETY AND INTEGRITY OF THE PRODUCT IS ONLY GUARANTEED IF ALL INSPECTIONS, MAINTENANCE AND REPAIRS ARE PERFORMED BY MAQUET ENGINEERS OR TRAINED AND AUTHORIZED TECHNICAL SUPPORT TECHNICIANS ¿ WHICH DOES NOT APPEAR TO HAVE BEEN THE CASE. THE SPEED OF THE CUPOLA LIGHT OF DRIFTING IS SIMULATED TO HAVE BEEN VERY LOW AND THE MOVEMENT IS VERY LIMITED ¿ IT ONLY MOVES IN THE DIRECTIONS ALLOWED BY THE DESIGN. EVEN IF THE CUPOLA MAKES A CONTACT WITH THE SURGEON HEAD IT WOULD NOT CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY OR MEDICAL INTERVENTION TO PREVENT HARM TO THE SURGEON. ILLUMINATION LEVELS ABOVE THE OPEN WOUND ARE GENERALLY ENSURED BY TWO LIGHT HEADS OF A SURGICAL LIGHT SYSTEM, AS REQUIRED BY THE STANDARD. THEREFORE, IF ONE CUPOLA DRIFTS AWAY, THE WOUND IS STILL SUFFICIENTLY ILLUMINATED BY THE SECOND CUPOLA. THE REVIEW OF INFORMATION DOCUMENTED IN INVESTIGATION DRIVES US TO CONCLUDE THE RISK LEVEL ASSOCIATED WITH THE ISSUE ACCEPTABLE. THERE WAS NO INJURY REPORTED. HOWEVER WE DECIDED TO REPORT THIS CASE IN THE ABUNDANCE OF CAUTION. BASED ON OUR FURTHER INVESTIGATION AND RISK EVALUATION WE NOW BELIEVE THAT THIS KIND OF THE EVENT IS NOT REPORTABLE TO THE COMPETENT AUTHORITIES. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE ISSUE WOULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 1

    ON 13TH APRIL MAQET (B)(4) BECAME AWARE OF AN INCIDENT CONNECTED WITH PRISMALIX 6401 DEVICE. AS IT WAS STATED LIGHT WAS DRIFTING AND MAY HAVE CONTACTED A DOCTOR'S HEAD. (B)(4).

    Description of Event or Problem · 1

    MFR REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336719 PRISMALIX 6401 SAL/DF/T LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1