LUCEA 40

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 28TH NOVEMBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. AS IT WAS STATED, THE SPRING ARM JOINT WAS WORN AND ONE FIXING POINT OF COVERS IS BROKEN. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES NEXT TO THE SCREW. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION IN CASE OF REOCCURRENCE.

Description of Event or Problem

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. AS IT WAS STATED, THE SPRING ARM JOINT WAS WORN, AND ONE FIXING POINT OF COVERS IS BROKEN. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THE HEADLIGHT COVER WAS CRACKED WITH MISSING PARTICLES NEXT TO THE SCREW. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE INFECTION IN CASE OF REOCCURRENCE. 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. 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 AT THE EDGE OF THE FIXING HOLES OF TRANSPARENT HOUSING AND HANDLE INTERFACE WERE PROBABLY CAUSED BY THE INCOMPATIBILITY OF THE CLEANING PROTOCOL OR AN ABNORMAL USE. THE USER MANUAL REF.01711 DESCRIBES HOW TO CLEAN AND DISINFECT THE LIGHT HEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID MECHANICAL STRESSES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE USER MANUAL REF.01711 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. TO PREVENT SIMILAR EVENT THE USER MANUAL REF. 01711 MENTIONS TO CHECK THE LIGHT HEADS DURING DAILY INSPECTION. 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 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. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016.