BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED

    MDR report key: 22455892 · Received July 9, 2025

    Report

    Report Number
    9710055-2025-0000178
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 5, 2025
    Report Date
    July 9, 2025
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED, THAT THREE BOLTS SNAPPED OFF, ONE WAS LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT AND SERIOUS INJURY. 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. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT THE MANUFACTURER. AS THEY STATED, IT WAS REPORTED THAT SCREWS, THAT CONNECT THE LIGHT HEAD FORK TO THE FRAME, SHEARED OFF. ACCORDING TO THE INFORMATION PROVIDED THE BEAM WAS PARTIALLY DETACHED FROM THE FRAME AND A SCREW WAS STILL CONNECTED TO THE FRAME. A PROGRESSIVE LOOSENING OF A SCREW OR AN EXCESSIVE EFFORT APPLIED ON THE LIGHT HEAD PROBABLY LED TO THE RUPTURE OF THE SCREW. TO PREVENT THE LOOSENING AND THEN RUPTURE OF THE SCREWS, THE PRODUCTION ASSEMBLY PROCEDURE "GOM 5344" INDICATES TO USE LOCTITE 243 THREADLOCKER ON THE 3 FIXING SCREWS. THE POWERLED INSTRUCTION FOR USE IFU 01581 MENTIONS TO CHECK THE INTEGRITY OF THE DEVICE PERFORMING, BY TRAINED PERSONNEL, DAILY VISUAL AND FUNCTIONAL INSPECTIONS TO ENSURE THAT THE PRODUCT USED IS COMPLIANT. 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). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. 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

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 300. IT WAS STATED, THAT THREE BOLTS SNAPPED OFF, ONE WAS LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION MAY LEAD TO THE DEVICE DETACHMENT AND SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124027 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568330999

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown