LUCEA 10/40

Additional Manufacturer Narrative

THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN 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. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF THE EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THAT DURING DAILY CHECK THE TRANSPARENT PLASTIC COVER CRACK WAS FOUND. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE HEADLIGHT UPPER COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN THE ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING THE EXAMINATION PROCEDURE MAY CAUSE INFECTION. THE DEFECTIVE PARTS (ARD368606555 - TRANSPARENT PLASTIC COVER - LUCEA 40, ARD368605998 - HANDLE INTERFACE WITH FORK - LUCEA 40) WERE REPLACED AND THE 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 THE PATIENT UPON THE EVENT OCCURRENCE AS THE ISSUE WAS FOUND DURING DAILY CHECK. 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

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

Additional Manufacturer Narrative

EVENT SITE NAME: (B)(6). EVENT SITE POSTAL CODE: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

Description of Event or Problem

ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THAT DURING DAILY CHECK THE TRANSPARENT PLASTIC COVER CRACK WAS FOUND. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE HEADLIGHT UPPER COVER WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION.