LUCEA 10

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 EXAMINATION LIGHTS - LUCEA 10. THE RECEIVED CUSTOMER ALLEGATION REGARDED A NON REPORTABLE ISSUE. ON (B)(6) 2022 TECHNICIAN BECAME AWARE OF REPORTABLE ISSUE - THE HEADLIGHT WAS DETACHED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

Description of Event or Problem

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

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.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10. THE INITIALLY RECEIVED CUSTOMER ALLEGATION WAS COVERING NON-REPORTABLE ISSUE. ON 5TH APRIL 2022 TECHNICIAN BECAME AWARE OF A REPORTABLE ISSUE ¿ CRACKS IN THE HEADLIGHT¿S COVERS, LEADING TO THEIR DETACHMENT. WE DECIDED TO REPORT THE ISSUE IN AN ABUNDANCE OF CAUTION AS FALLING OFF OF ANY PARTS MAY LEAD TO INFECTION. ACCORDING TO THE INFORMATION PROVIDED BY THE SERVICE UNIT, THE DEVICE HAS BEEN REPAIRED BY THE REPLACEMENT OF FAULTY PARTS - TRANSPARENT PLASTIC COVER - LUCEA 10 AND L10-HANDLE INTERFACE WITH FLEXIBLE V2. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION, SINCE CRACKS IN COVERS LEADING THE DETACHMENT OF HEADLIGHT COULD BE CONSIDERED AS A TECHNICAL DEFICIENCY, AND IN THIS WAY THE DEVICE CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUE WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENTS ARE OCCURRING AT A MODERATE RATIO. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. AS PER EXPERTISE PERFORMED BY THE SUBJECT MATTER EXPERT AT MANUFACTURING SITE THE CRACKS DETECTED ON THE HANDLE INTERFACE AND TRANSPARENT COVER FIXING POINTS WERE PROBABLY CAUSED BY IMPROPER USE, COLLISIONS, INCOMPATIBLE CLEANING PRODUCTS OR PROTOCOL. TO PREVENT ANY INCIDENT THE USER MANUAL FOR LUCEA 10/40 (IFU 01701 EN 11) ON PAGE 21 MENTIONS TO CHECK THE INTEGRITY OF THE LIGHT HEADS DURING DAILY INSPECTION. FURTHERMORE, THE SAME USER MANUAL ON PAGES 28-29 EXPLAINS HOW TO CLEAN AND DISINFECT THE LIGHTHEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID TORQUES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE USER MANUAL FOR LUCEA 10/40 (IFU 01701 EN 11) ON PAGE 24 MENTIONS TO HANDLE THE LIGHT HEAD BY THE HANDLE. WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER¿S RECOMMENDATION HAD BEEN FOLLOWED THE INCIDENT COULD 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.

Description of Event or Problem

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