BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 11789416 · Received May 7, 2021

    Report

    Report Number
    9710055-2021-00170
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    February 26, 2021
    Report Date
    June 2, 2021
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 26TH OF FEBRUARY 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS - POWERLED. THE CAMERA'S SUPPORT WAS BROKEN, LEADING TO DETACHMENT OF THE CAMERA. NO INFORMATION ABOUT ANY INJURY WAS PROVIDED HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING INTO STERILE FIELD MIGHT LED TO SERIOUS INJURY OR CONTAMINATION. GETINGE TECHNICIANS REPLACED DEFECTIVE PARTS AND UNIT WAS RETURNED TO USAGE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS THE SUPPORT SHOULD NOT BREAK, AND THE DEVICE CONTRIBUTED TO EVENT. THERE IS NO INFORMATION IF AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS OR WAS NOT BEING USED FOR THE PATIENT TREATMENT. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. THE SEPARATION OF THE CAMERA WAS CAUSED BY A WEARING OUT AND TEARING OF THE BASE FIXING HOLE, DUE TO REPETITIVE STRESSES DURING THE MANIPULATION OF THE CAMERA. THE INVOLVED PLASTIC PART 567801057 IN PPS FORTRON HAS BEEN REPLACED BY A STEEL PART 567801181 IN JANUARY 2011 UNDER MODIFICATION FILE # E090520. THE KIT 367265555, INCLUDING THE BASE 567801181 IN STEEL WAS AVAILABLE FROM JULY 2010. WE RECOMMEND UPDATING THE SIMILAR CAMERAS, IN PREVENTIVE MEASURE, IN THIS FACILITY. BASED ON THE LOW OCCURRENCE RATE, THE MODIFICATION IS NOT MANDATORY. CURRENTLY THE CAMERAS # 567203945, 567203944, 567501246, 567501248 ARE NOT ANY MORE DISTRIBUTED. FROM JANUARY 2011 ALL THE CAMERAS SUPPLIED ARE EQUIPPED WITH THE STEEL BASE. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GIVEN THE CIRCUMSTANCES AND AFTER OUR REVIEW OF COMPLAINT RATIO BEHAVIOR 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

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS - POWERLED. THE CAMERA'S SUPPORT WAS BROKEN, LEADING TO DETACHMENT OF THE CAMERA. NO INFORMATION ABOUT ANY INJURY WAS PROVIDED HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING INTO STERILE FIELD MIGHT LED TO SERIOUS INJURY OR CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691048 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568370939

    Patients

    Seq Age Sex Outcome Treatment
    1