LUCEA 10/40

Description of Event or Problem

ON 1ST AUGUST, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCIA 10/40 MOBILE. BASED ON PHOTOGRAPHIC EVIDENCE DCU FOUND THAT THE COVER ON THE FORK WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

Additional Manufacturer Narrative

EVENT SITE NAME: EVENT SITE CITY: (B)(6). EVENT SITE TELEPHONE: (B)(6). INITIAL REPORTER WAS MEDICAL STAFF. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

THE CORRECTION OF D4 CATALOG #, D4 SERIAL #, H3A DEVICE EVALUATED BY MFG, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE-EXPLAIN DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D4 CATALOG #: ARDLCA309008A, CORRECTED D4 CATALOG #: ARD568602978. PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: (B)(6). PREVIOUS H3A DEVICE EVALUATED BY MFG: NO CORRECTED H3A DEVICE EVALUATED BY MFG: YES PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: NONE PREVIOUS H3C IF OTHER PROVIDE CODE-EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER CORRECTED H3C IF OTHER PROVIDE CODE-EXPLAIN: NONE. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 10/40 MOBILE. BASED ON PHOTOGRAPHIC EVIDENCE DCU FOUND THAT THE COVER ON THE FORK WAS CRACKED WITH MISSING PARTICLES. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. THE ISSUE WAS SOLVED BY REPLACEMENT OF THE DEVICE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AT THE MANUFACTURER. AS THEY STATED: IT WAS REPORTED THAT THE PLASTIC PROTECTION OF THE FLEXIBLE HOSE USED TO POSITION THE LUCEA 10 EXAMINATION LIGHT WAS DAMAGED. ACCORDING TO THE INFORMATION AND PHOTOGRAPHIC EVIDENCE PROVIDED, THE CAUSE OF THE DETERIORATION OF THE PLASTIC PROTECTION OF THE HOSE IS DUE TO A NORMAL WEAR AND TEAR CAUSED BY REPEATED MOVEMENTS OF THE HOSE OVER A LONG PERIOD OF TIME (FOR 9 YEARS, THE LUCEA 10 ARD5686029780 SN(B)(6) INVOLVED WAS MANUFACTURED IN 2014). 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).