BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCEA 50

    MDR report key: 7221377 · Received January 26, 2018

    Report

    Report Number
    9710055-2018-00005
    Event Type
    Injury
    Date Received
    January 26, 2018
    Date of Event
    December 31, 2017
    Report Date
    May 24, 2018
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K113679
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 LUCEA 50 DEVICE. AS IT WAS STATED BY THE CUSTOMER, THE SUSPENSION OF THE LIGHT HAS SPONTANEOUSLY DECOMPOSED ON ONE OF THE JOINTS AFTER THE CLEANING AND DISINFECTION PROCESS: A CIRCLIP DETACHED AND THE SURGICAL LIGHT FELL TO THE FLOOR. AS AN EFFECT OF THIS EVENT, THE CLEANER IS ALLEGED TO HAVE SUSTAINED A SPINAL INJURY, WHICH IS CONSIDERED TO BE SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO 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 THE OCCURRENCE RATE FOR THE ISSUE OF THE ARM JOINT CIRCLIP RESULTING IN THE LIGHT HEAD FALLING OFF THE DEVICE IS LOW (TOTAL OF 2 COMPLAINTS IN THE LAST 5 YEARS OF DAILY USE OF A LARGE NUMBER OF SIMILAR DEVICES). THE CIRCLIP INVOLVED IN THE EVENT WAS RETURNED AND CHECKED BY MAQUET (B)(4) ENGINEERS AND NO FAULT HAS BEEN FOUND. IT APPEARS THAT THE EVENT OCCURRED AS FOLLOWS: ARM JOINT CIRCLIP WAS INCORRECTLY FITTED AT THE INSTALLATION OR AFTER SPRING ARM EXCHANGE, AS A RESULT: ARM JOINT CIRCLIP WAS NOT FULLY SEATED IN ITS GROOVE, AND AS A RESULT; MECHANICAL COUPLING BETWEEN THE SPRING ARM AND THE MAIN ARM FAILED, CAUSING LIGHT HEAD DETACHED FROM THE SPRING ARM. NOTE THAT THE FITTING OF THE JOINT CIRCLIP IS NOT PERFORMED AT CONSTRUCTION BUT DURING INSTALLATION ON-SITE OR DURING REPLACEMENT WORK ON-SITE. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. 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 THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE WILL BE INVESTIGATED BY MANUFACTURING SITE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE

    Description of Event or Problem · 1

    ON (B)(6) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- LUCEA 50. AS IT WAS STATED BY CUSTOMER, THE SUSPENSION OF THE LIGHT AFTER THE CLEANING AND DISINFECTION PROCESS HAS SPONTANEOUSLY DECOMPOSED ON ONE OF JOINTS. SURGICAL LIGHT FELL TO THE FLOOR. CLEANER UNDERWENT SPINAL INJURY. MANUFACTURER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64379 LUCEA 50 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization