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 ONE OF EXAMINATION LIGHTS - LUCEA. AS IT WAS STATED, THE HEADLIGHT COVER WAS CRACKED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT CAUSE A CONTAMINATION.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA. AS IT WAS STATED, THE HEADLIGHT COVER WAS CRACKED. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT CAUSE A CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AS PARTICLES OF COVER WERE MISSING, AND IT CONTRIBUTED TO THE EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. 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. REVIEW WAS PERFORMED AND ALL RECORDS WERE SEARCHED FOR ANY INDICATION ABOUT CRACK OF LUCEA¿S 10/40 HEADLIGHT. ALTOGETHER 14 CUSTOMER COMPLAINTS WERE REPORTED DUE TO MENTIONED ISSUE. THE COMPLAINT RATIO IS CONSIDERED AS LOW. AS PER THE INVESTIGATION BY SUBJECT MATTER EXPERTS AT THE MANUFACTURING SITE, THE PROBABLE CAUSE OF THE BREAKAGE IS THE INCOMPATIBILITY OF THE CLEANING PRODUCTS OR ABNORMAL USE, I.E. COLLIDING DEVICES. MANUFACTURER RECOMMENDS TO FOLLOW THE IFU REGARDING VISUAL INSPECTION BEFORE USE. A DAILY INSPECTION PERFORMED BY THE USER WILL HELP PREVENTING SUCH EVENT. MOREOVER, MANUFACTURER RECOMMENDS TO INFORM THE CUSTOMER ABOUT THE HAZARDS IN CASES OF NON-COMPLIANCE OF THESE INSTRUCTIONS. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GIVEN THE CIRCUMSTANCES AND AFTER OUR REVIEW OF COMPLAINT RATIO BEHAVIOR OF THIS NATURE, WE 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 REFERENCE NUMBER: (B)(4).