BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERLED 500

    MDR report key: 18003469 · Received October 25, 2023

    Report

    Report Number
    9710055-2023-00812
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    October 19, 2023
    Report Date
    October 25, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 500. IT WAS STATED THE HEADLIGHT IS BROKEN AND OFF THE ARM. THE ISSUE OCCURRED DURING DAILY CLEANING BY CLEANING PERSONNEL. MOREOVER, THE TECHNICIAN CONFIRMED THE CUPOLA WAS HANGING ON CABLES AND PAINT CHIPPING OCCURRED AS RESULT OF FAILURE. BASED ON PROVIDED PHOTOGRAPHIC EVIDENCE HEADLIGHT COVER WAS CRACKED WITH POSSIBILITY OF MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. DEFECTIVE PARTS PWD500 UNDERFACE TRANSPARENT PLATE (ARD368325555), PWD 500 - S/A BEAM (ARD368350998) AND SET COVER WITH EXTERNAL HANDLE-PWD500 (ARD368330998) WERE REPLACED AND DEVICE WAS BACK TO USAGE. 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. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ACCORDING TO THE INFORMATION GATHERED, THE ISSUE WAS DISCOVERED DURING DAILY CLEANING. AS PER EXPERTISE PERFORMED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE, IT WAS REPORTED THAT A SCREW, THAT CONNECT THE BEAM TO THE FRAME, SHEARED OFF. THREE SCREWS ENABLE THE MECHANICAL CONNECTION BETWEEN THE BEAM AND THE FRAME. ACCORDING TO THE PHOTOGRAPHIC EVIDENCES, THE BEAM WAS PARTIALLY DETACHED FROM THE FRAME SHOWING A DETECTABLE LARGE OPENING 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. THIS PROCEDURE WAS INITIALLY ISSUED IN 2011, WHILE THE AFFECTED DEVICE WAS MANUFACTURED IN 2013. THEREFORE, THE AFOREMENTIONED SCENARIO CAN BE RULED OUT. THE POWERLED INSTRUCTION FOR USE 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. THE CORRECTION OF H3A: DEVICE EVALUATED BY MANUFACTURER, H3B: DEVICE NOT EVAL PROVIDE CODE, H3C: IF OTHER PROVIDE CODE - EXPLAIN, H6: COMPONENT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A: DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A: DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B: DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B: DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C: IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C: IF OTHER PROVIDE CODE - EXPLAIN: N/A. PREVIOUS H6: COMPONENT CODES: MECHANICAL/COATING MATERIAL//4768. MECHANICAL/COVER//772. MECHANICAL/JOINT//854. CORRECTED H6: COMPONENT CODES: MECHANICAL/COATING MATERIAL//4768. MECHANICAL/COVER//772. MECHANICAL/FASTENER/SCREW/568.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    ON 19TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 500. IT WAS STATED THE HEADLIGHT IS BROKEN AND OFF THE ARM. THE ISSUE OCCURRED DURING DAILY CLEANING BY CLEANING PERSONNEL. MOREOVER, THE TECHNICIAN CONFIRMED THE CUPOLA WAS HANGING ON CABLES AND PAINT CHIPPING OCCURRED AS RESULT OF FAILURE. BASED ON PROVIDED PHOTOGRAPHIC EVIDENCE HEADLIGHT COVER WAS CRACKED WITH POSSIBILITY OF MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700459 POWERLED 500 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARD568350933

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown