LUCEA 40

Description of Event or Problem

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

Additional Manufacturer Narrative

INITIAL REPORTER: DISTRIBUTOR. 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 EXAMINATION LIGHTS ¿ LUCEA 10/40. IT WAS DISCOVERED THAT THE HANDLE INTERFACE WITH FORK WAS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE THAT THE HEADLIGHT'S ATTACHMENT POINT WAS BROKEN RESULTING IN THE DETACHMENT OF HEADLIGHT FROM FORK. ADDITIONALLY, THREE FIXING SCREWS HOLDING THE DEVICE SUSPENSION ARM WERE CONFIRMED TO BE LOOSE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS THE ISSUE CAN CAUSE SERIOUS INJURY 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. THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. 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 STANDARD UL60601-1. FURTHERMORE, THESE CASES REMAIN ISOLATED. ADDITIONALLY, THERE IS NO INFORMATION ABOUT LOOSENING THE 3 SCREWS AND THE MAINTENANCE AFTER DELIVERY. THE LOOSENING OF THE SCREWS IS DUE TO LACK OF MAINTENANCE OR AN INCORRECT INSTALLATION OR REINSTALLATION. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Additional Manufacturer Narrative

THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY.

Description of Event or Problem

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

Description of Event or Problem

ON 9TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. AS IT WAS STATED, THE HANDLE INTERFACE WITH FORK WAS DAMAGED. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE THAT THE HEADLIGHT'S ATTACHMENT POINT WAS BROKEN RESULTING IN THE DETACHMENT OF HEADLIGHT FROM FORK. ADDITIONALLY, THREE FIXING SCREWS HOLDING THE DEVICE SUSPENSION ARM WERE CONFIRMED TO BE LOOSE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS DETACHMENT OF HEADLIGHT AS WELL AS LOOSE SCREWS HOLDING THE DEVICE CONFIGURATION AND CREATING A RISK OF THE DEVICE FALL MAY RESULT IN SERIOUS INJURY IN CASE OF REOCCURRENCE.

Additional Manufacturer Narrative

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