LUCEA 10/40

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10/40 RAIL. IT WAS STATED THE TRANSPARENT AND SUPPORT COVERS WERE BROKEN. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE UNDERSIDE AND UPPER HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. THE AFFECTED DEVICE WAS REPAIRED BY REPLACING DEFECTIVE PARTS ARD368601555 TRANSPARENT PLASTIC COVER - LUCEA 10 AND ARD368606997 L10-HANDLE INTERFACE WITH FLEXIBLE V2. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION DUE TO CRACKS AND MISSING PARTICLES FROM COVER, WHICH CONTRIBUTED TO THE EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. REVIEW OF RECEIVED CUSTOMER PRODUCT COMPLAINTS RELATED TO INVESTIGATED ISSUE, REVEALED THAT THERE WERE NO INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. WE FIND THAT THE FAILURE RATIO OF CRACKS AND MISSING PARTICLES ON LUCEA 10/40 DEVICES IS MODERATE. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT MANUFACTURING SITE. BASED ON SOME INTERNAL TEST DONE BY MAQUET SAS (REF: CRE 12-085 FOR INSTANCE), ONLY ABNORMAL USE (VIOLENT COLLISIONS, EXCESSIVE PRESSURE¿) OR THE USE OF INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL, CAN DAMAGE THIS DEVICE AS REPORTED IN THIS COMPLAINT. THE USER MANUAL EXPLAINS HOW TO CHECK THE LIGHT HEADS DURING DAILY INSPECTION (ATTACHMENT 1_IFU_LUCEA_10_40_01701EN12, PAGES 22-23). TO AVOID ANY SIMILAR INCIDENT, THE LUCEA PRODUCT MUST BE USED ACCORDING WITH THE USER MANUAL INFORMATION (ATTACHMENT 1_IFU_LUCEA_10_40_01701EN12, PAGES 22-25). GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO 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). INITIAL REPORTER WAS NURSING ASSISTANT. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 5TH JANUARY, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10/40 RAIL. IT WAS STATED THE TRANSPARENT AND SUPPORT COVERS WERE BROKEN. IT WAS CONFIRMED BY PHOTOGRAPHIC EVIDENCE THE UNDERSITE AND UPPER HEADLIGHT COVERS WERE CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.