BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 17274708 · Received July 6, 2023

    Report

    Report Number
    9710055-2023-00490
    Event Type
    Malfunction
    Date Received
    July 6, 2023
    Report Date
    July 6, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ LUCEA 50/100. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS MISSING AND PLASTIC COVERS WERE CRACKED RESULTING IN MISSING PARTICLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE ISSUE OCCURRED DUE TO INCORRECT HANDLING OF THE EQUIPMENT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO MISSING COVER AND CRACKED COVERS WITH MISSING PARTICLES, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION, IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LED TO SERIOUS INJURY NOR DEATH. COMPARING THE NUMBER OF INVOLVED DEVICES TO THE INSTALL BASE, WE CONCLUDE THAT THE FAILURE RATIO FOR THE INVESTIGATED ISSUE IS MODERATE. AS STATED BY THE SUBJECT MATTER EXPERT AT THE MANUFACTURER¿S SITE, CRACKS LOCATED ON THE LIGHT HEAD LOWER COVERS, AT THE EDGE OF THE ON/OFF BUTTON, CAN BE DETECTED DURING DAILY VISUAL INSPECTION, AS RECOMMENDED BY THE USER MANUAL (01741 REV. 11, PAGES 27-28). 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 (01741 REV. 11, PAGES 46-49) 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 LUCEA50-100 USER MANUAL (01741 REV. 11, PAGES 27-28) MENTIONS: ¿CHECK THE LIGHT HEADS FOR CHIPPED PAINT, IMPACT MARKS AND ANY OTHER DAMAGES¿ DURING THE DAILY INSPECTIONS. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GETINGE 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

    ON (B)(6)2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ LUCEA 50/100. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS MISSING AND PLASTIC COVERS WERE CRACKED RESULTING IN MISSING PARTICLE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422066 LUCEA 50/100 LAMP, SURGICAL FTD MAQUET SAS ARD569070999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown