LUCEA 40

Additional Manufacturer Narrative

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

Description of Event or Problem

ON (B)(6) 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT. THE DROP OF DEVICE OCCURRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF D4 CATALOG # AND SERIAL # FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG # ARD569072999. SERIAL # (B)(6). CORRECTED D4 CATALOG # ARD568601997. SERIAL # (B)(6).

Description of Event or Problem

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

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

ON 22ND JUNE 2021, GETINGE BECAME AWARE OF AN ISSUE WITH LUCEA 40 LIGHT RELATED TO A DROP OF THE EQUIPMENT, AND INDICATION THAT THE CUPOLA FITTINGS BROKE. IT COULD NOT BE CONFIRMED WHETHER THE DROP OCCURRED AS AN EFFECT OF THE DEVICE MALFUNCTION OR IT WAS RELATED TO THE CUSTOMER OPERATIONAL CONTEXT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF MAY CAUSE POTENTIAL INFECTION OR INJURY. THE GETINGE SERVICE TECHNICIAN REPLACED, REINSTALLED AND TESTED THE LIGHTHEAD. AFTER REPAIR, THE LIGHT WAS WORKING PROPERLY AND WAS RETURNED TO SERVICE. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET THE MANUFACTURER¿S SPECIFICATION AS THE LIGHT HEAD FELL OFF AND IT CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. PERFORMED TREND REVIEW REVEALED NO SIGNIFICANT TREND INCREASES FOR CUSTOMER PRODUCT COMPLAINTS RELATED TO THE INVESTIGATED FAILURE MODE. THE COMPLAINT RATE WAS ESTABLISHED AT THE VERY LOW LEVEL OF APPROXIMATELY 0.03%. WHEN REVIEWING SIMILAR REPORTABLE EVENTS FOR THE SAME DEVICE TYPE, WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. DUE TO THE LIMITED INFORMATION AVAILABLE, THE SUBJECT MATTER EXPERTS FORM THE MANUFACTURING SITE WERE NOT ABLE TO DEFINE AN ACTUAL ROOT CAUSE OF THE SITUATION OCCURRENCE. THE CONTRIBUTORY FACTORS WHICH MIGHT HAVE HAD AN INFLUENCE ON THE OCCURRENCE WERE ESTABLISHED AS IMPROPER USE OR IMPROPER HANDLING OF EQUIPMENT. WE BELIEVE THAT OVERALL THE DEVICES ON THE MARKET ARE PERFORMING CORRECTLY. GIVEN THE CIRCUMSTANCES WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.