LUCEA LED®

Description of Event or Problem

ON 9TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 10 (RAIL VERSION). IT WAS STATED THE STRUCTURE OF THE EXAMINATION LAMP WAS DAMAGED AND SOME PARTICLES WERE FALLING OFF THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, B3 DATE OF EVENT, D4 CATALOG #, H4 MANUFACTURE DATE, H3A DEVICE EVALUATED BY MFG, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE-EXPLAIN DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 9TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 10 (RAIL VERSION). IT WAS STATED THE STRUCTURE OF THE EXAMINATION LAMP WAS DAMAGED AND SOME PARTICLES WERE FALLING OFF THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 9TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10 RAIL. IT WAS STATED THE HEADLIGHT COVER WAS CRACKED IN THE FIXING MADE BY 3 SCREWS WITH POSSIBILITY OF MISSING PARTICLES. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT SOME PARTICLES WERE MISSING FROM COVER. ACCORDING TO THE TECHNICAL ANALYSIS, THE PROBLEM OCCURRED DUE TO IMPROPER USE OF THE DEVICE BY HOLDING THE DEVICE IN THE ILLUMINATION ZONE INSTEAD OF USING THE HANDLE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. PREVIOUS B3 DATE OF EVENT : 10/09/2023. CORRECTED B3 DATE OF EVENT : 10/03/2023. PREVIOUS D4 CATALOG # ARDLCA409005A. CORRECTED D4 CATALOG # NONE. PREVIOUS H4 MANUFACTURE DATE: 2021-07-15. CORRECTED H4 MANUFACTURE DATE: 2021-07-16. PREVIOUS H3A DEVICE EVALUATED BY MFG: NO. CORRECTED H3A DEVICE EVALUATED BY MFG: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: NONE. PREVIOUS H3C IF OTHER PROVIDE CODE-EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE-EXPLAIN: NONE. INITIAL REPORTER WAS A PERSON FROM ECONOMIC SERVICES. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10 RAIL. IT WAS STATED THE HEADLIGHT COVER WAS CRACKED IN THE FIXING MADE BY 3 SCREWS WITH POSSIBILITY OF MISSING PARTICLES. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT SOME PARTICLES WERE MISSING FROM COVER. ACCORDING TO THE TECHNICAL ANALYSIS, THE PROBLEM OCCURRED DUE TO IMPROPER USE OF THE DEVICE BY HOLDING THE DEVICE IN THE ILLUMINATION ZONE INSTEAD OF USING THE HANDLE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THERE IS NO INFORMATION IF THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. THE CRACKS DETECTED ON THE HANDLE INTERFACE AND TRANSPARENT COVER FIXING POINTS WERE PROBABLY CAUSED BY IMPROPER USE, COLLISIONS, INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL. TO PREVENT ANY INCIDENT THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION AND DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEAD. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE LUCEA10/40 INSTRUCTION FOR USE IFU 01701 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

ON 9TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10 RAIL. IT WAS STATED THE HEADLIGHT COVER WAS CRACKED IN THE FIXING MADE BY 3 SCREWS WITH POSSIBILITY OF MISSING PARTICLES. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT SOME PARTICLES WERE MISSING FROM COVER. ACCORDING TO THE TECHNICAL ANALYSIS, THE PROBLEM OCCURRED DUE TO IMPROPER USE OF THE DEVICE BY HOLDING THE DEVICE IN THE ILLUMINATION ZONE INSTEAD OF USING THE HANDLE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.