BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 19664691 · Received July 3, 2024

    Report

    Report Number
    9710055-2024-00404
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER FOR THE MEDICAL DEVICE REFERRED TO IN THIS MEDICAL DEVICE REPORT HAS NOT BEEN RECEIVED, AND THEREFORE, NO UDI NUMBER CAN BE PROVIDED. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE UPPER AND LOWER HEADLIGHT COVERS WERE BROKEN WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. AS STATED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE, CRACKS LOCATED ON THE LIGHT HEAD LOWER COVERS, AT THE EDGE OF THE ON/OFF BUTTON, WERE DETECTED DURING DAILY VISUAL INSPECTION, AS RECOMMENDED BY THE USER MANUAL. BASED ON THE INVESTIGATIONS THE MOST PROBABLE ROOT CAUSE OF THE CRACKS IS A COMBINATION OF DIFFERENT FACTORS: MECHANICAL STRESS, USE OF INAPPROPRIATE CLEANING/DISINFECTION PRODUCTS, OR INAPPROPRIATE CLEANING AND DISINFECTION PROTOCOLS. IF THE DESCRIBED FAILURE OCCURS, THE USER CAN VISUALLY DETECT IT DURING THE DAILY CHECKS TO BE PERFORMED PRIOR TO EACH USE, OR DURING PREVENTIVE MAINTENANCE. IN THIS CASE, THE USER WOULD CONTACT A GETINGE REPRESENTATIVE TO REPLACE THE DEFECTIVE COVERS OF THE AFFECTED DEVICE. FOR CLEANING, THE IFU INFORMS THE USER TO NOT USE AGGRESSIVE AND ABRASIVE PRODUCTS. DURING DISINFECTION, IT IS PROHIBITED TO SPRAY THE DISINFECTANT SOLUTION DIRECTLY ON THE DEVICE AND TO USE INAPPROPRIATE DISINFECTANTS. TO PREVENT ANY INCIDENT THE LUCEA 50-100 USER MANUAL MENTIONS: ¿CHECK THE LIGHT HEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGES¿ DURING THE DAILY INSPECTIONS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON 26TH JUNE, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED AND CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE UPPER AND LOWER HEADLIGHT COVERS WERE BROKEN WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602485 LUCEA 50/100 LAMP, SURGICAL FTD MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown