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) 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, THE HEADLIGHT DETACHED FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AS DETACHMENT OF THE HEADLIGHT CAN LEAD TO SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 40. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE, THE HEADLIGHT DETACHED FROM THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION AS DETACHMENT OF THE HEADLIGHT CAN LEAD TO SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE. THE DETACHED HEADLIGHT WAS REPLACED AND THE DEVICE WAS RETURNED TO USE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION, GIVEN THE HEADLIGHT DETACHMENT, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. IT REMAINS UNKNOWN WHETHER THE AFFECTED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT OCCURRED. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS OCCURRING AT A VERY LOW RATIO ON LUCEA 10/40. ACCORDING TO THE SUBJECT MATTER EXPERT (SME) AT MANUFACTURING SITE, THE LIGHTHEAD WAS NOT ATTACHED TO THE FORK ANYMORE. BASED ON PROVIDED PHOTOGRAPHIC EVIDENCE, ACCORDING TO THE SME, IT CAN BE NOTICED THAT THE LIGHTHEAD SHOWS SIGNS OF DAMAGE WHICH ARE LIKELY CAUSED BY A STRONG SHOCK. REVIEW OF CUSTOMER PRODUCT COMPLAINTS REGISTERED FOR ALL SURGICAL LIGHTS MANUFACTURED BY MAQUET SAS SHOWS THAT THERE HAVE BEEN CASES REPORTED DUE TO THE HEADLIGHT¿S DETACHMENT. HOWEVER, ACCORDING TO OUR SME STATEMENT, THIS IS THE FIRST CASE REPORTED FOR THE ISSUE OF TOTAL BREAKAGE OF LUCEA 40 LIGHT HEAD WHICH HAPPENED DUE TO THE COLLISION OR DAMAGE CAUSE BY EXTERNAL FORCE, E.G. IMPACT BY ANOTHER EQUIPMENT. WITH ALL INFORMATION AT HAND, THE SME STATED THAT THE MOST LIKELY ROOT CAUSE OF THIS EVENT IS A MISUSE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Additional Manufacturer Narrative

ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. THE CORRECTION OF D4 CATALOG #, D4 VERSION OR MODEL # AND D4 SERIAL # FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG # ARDLCA109001A. CORRECTED D4 CATALOG # ARD568601998. PREVIOUS D4 VERSION OR MODEL # ARDLCA109001A. CORRECTED D4 VERSION OR MODEL # ARD568601998. PREVIOUS D4 SERIAL # (B)(6). CORRECTED D4 SERIAL # (B)(6).

Description of Event or Problem

MANUFACTURER REFERENCE NUMBER (B)(4).