BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUCEA 50/100

    MDR report key: 12656031 · Received October 19, 2021

    Report

    Report Number
    9710055-2021-00332
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    August 3, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3RD OF AUGUST 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OPERATING LIGHTS- LUCEA 50/100. THE HEADLIGHT COVER WAS CRACKED AND PARTICLES WERE MISSING, WHICH WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE FALL OF ANY PARTICLES INTO STERILE FIELD MAY CAUSE CONTAMINATION. CUSTOMER ORDERED PARTS FOR REPLACEMENT. DEVICE WAS FIXED ON (B)(6) 2021 AND RETURNED TO USE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS PART OF HEADLIGHT WAS MISSING AND COVER WAS CRACKED, WHICH CONTRIBUTED TO EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. AFTER REVIEWING THE INFORMATION PROVIDED FOR THE CUSTOMER PRODUCT COMPLAINTS INVESTIGATED HERE, THE TREND IS CONSIDERED AS CONSTANT. THE ROOT CAUSE ANALYSIS OF THE ISSUE WITH HEADLIGHT COVER CRACKED HAS BEEN PERFORMED BY THE MANUFACTURING SITE. AS STATED, ACCORDING TO THE PHOTOGRAPHIC EVIDENCE PROVIDED, VISIBLE SCREWDRIVER MARKS CAUSED THE DETERIORATION OF THE COVER. THIS IS CONSIDERED A USER ERROR. TO PREVENT ANY INCIDENT THE LUCEA 50/100 INSTRUCTION FOR USE MENTIONS TO PERFORM A DAILY VISUAL INSPECTION OF THE LIGHT HEAD AS INDICATED IN IFU 01741 P. 53. WE BELIEVE THAT OVERALL THE DEVICES ON THE MARKET ARE PERFORMING CORRECTLY. GIVEN THE CIRCUMSTANCES 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

    MANUFACTURER REFERENCE NUMBER (B)(6).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OPERATING LIGHTS- LUCEA 50/100. THE HEADLIGHT COVER WAS CRACKED AND PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE FALL OF ANY PARTICLES INTO STERILE FIELD MAY CAUSE CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558673 LUCEA 50/100 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568604999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown