LUCEA 40

Additional Manufacturer Narrative

THE INITIAL REPORTER WAS MEDICAL SPECIALIST. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND 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 OUR EXAMINATION LIGHTS - LUCEA 40 (MOBILE VERSION). IT WAS STATED THE LAMP BODY COULD NOT BE USED BECAUSE PART OF THE LAMP WAS DAMAGED. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE THE COVER WAS BROKEN WITH MISSING PARTICLES WHICH RESULTS IN HEADLIGHT DETACHMENT, THE LABEL ON FORK WAS DAMAGED WITH RISK OF MISSING PARTICLES AND PAINT WAS PEELING FROM FORK. THE HOSPITAL STAFF NOTICED THE COVER DAMAGE WHILE CHECKING THE OPERATION, THE LAMP IS NOT IN USE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. 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. BASED ON SOME INTERNAL TEST DONE BY MAQUET SAS (REF: (B)(4) 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. 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

THE INITIAL REPORTER WAS MEDICAL SPECIALIST. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016. THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER?, H3B DEVICE NOT EVAL PROVIDE CODE AND 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 OUR EXAMINATION LIGHTS - LUCEA 40 (MOBILE VERSION). IT WAS STATED THE LAMP BODY COULD NOT BE USED BECAUSE PART OF THE LAMP WAS DAMAGED. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE THE COVER WAS BROKEN WITH MISSING PARTICLES WHICH RESULTS IN HEADLIGHT DETACHMENT, THE LABEL ON FORK WAS DAMAGED WITH RISK OF MISSING PARTICLES AND PAINT WAS PEELING FROM FORK. THE HOSPITAL STAFF NOTICED THE COVER DAMAGE WHILE CHECKING THE OPERATION, THE LAMP IS NOT IN USE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. 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. BASED ON SOME INTERNAL TEST DONE BY MAQUET SAS (REF: (B)(4) 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. 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).

Description of Event or Problem

ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS - LUCEA 40 (MOBILE VERSION). IT WAS STATED THE LAMP BODY COULD NOT BE USED BECAUSE PART OF THE LAMP WAS DAMAGED. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE THE COVER WAS BROKEN WITH MISSING PARTICLES WHICH RESULTS IN HEADLIGHT DETACHMENT, THE LABEL ON FORK WAS DAMAGED WITH RISK OF MISSING PARTICLES AND PAINT WAS PEELING FROM FORK. THE HOSPITAL STAFF NOTICED THE COVER DAMAGE WHILE CHECKING THE OPERATION, THE LAMP IS NOT IN USE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.

Additional Manufacturer Narrative

(B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.