LUCEA 10/40

Description of Event or Problem

ON 22ND MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES RESULTING IN HEADLIGHT'S DETACHMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. 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 DEVICES WERE OR WERE NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. THE ANALYSIS IS FOLLOWING: THE MOST LIKELY ROOT CAUSE IS A VIOLENT ROTATION OF THE LIGHT HEAD. THE TEST RE11-052 PROVES THAT THE STOP RESISTS TO 50 STRONG ROTATIONS AND IS COMPLIANT TO THE STANDART UL60601-1. REGARDING THE PICTURE TAKEN ON SITE THE ROOT CAUSE OF THIS THE BROKEN HANDLE IS A SHOCK WITH ANOTHER DEVICE GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN AND H8 USAGE OF THE DEVICE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 22ND MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 22ND MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES RESULTING IN HEADLIGHT'S DETACHMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION. 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 H8 USAGE OF THE DEVICE: INITIAL USE OF DEVICE. CORRECTED H8 USAGE OF THE DEVICE: REUSE. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016.

Description of Event or Problem

ON 22ND MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES RESULTING IN HEADLIGHT'S DETACHMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION.