LUCEA 40

Description of Event or Problem

ON 18TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE CONTROL BUTTON WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.

Additional Manufacturer Narrative

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

Description of Event or Problem

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

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE CONTROL BUTTON WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN AN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO A STERILE FIELD OR DURING A PROCEDURE MAY CAUSE CONTAMINATION. ON 30TH MAY 2022, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN AND IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THE MISSING ON/OFF BUTTON WAS PUSHED INTO THE DEVICE. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. ACCORDING TO THE INFORMATION PROVIDED BY THE SERVICE UNIT, THE DEVICE HAS BEEN REPAIRED BY THE REPLACEMENT OF A FAULTY PART - S/E INTERFACE POIGNEE AVEC ARCEAU - L40 (ARD368605998). BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE EXAMINATION LIGHT DID NOT MEET ITS SPECIFICATION, SINCE A DEFECTIVE ON/OFF BUTTON 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 DIAGNOSIS. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE INSTALL BASE WE CAN CONCLUDE THAT THE FAILURE RATIO IS VERY LOW. A ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERTS AND CONCLUDED THAT THE CAUSE OF THE ISSUE WITH ON/OFF BUTTON IS PROBABLY A MECHANICAL SHOCK. TO PREVENT ANY INCIDENTS, THE INSTRUCTION FOR USE (LUCEA 10-40 IFU 01701 REV. 11, PAGES 16, 21) OPERATING INSTRUCTIONS MENTION "THIS LIGHT MUST NOT BE USED IF IT IS DAMAGED" AND TO "CHECK THAT THE DEVICE HAS NOT SUFFERED ANY IMPACT DAMAGE" DURING DAILY CHECKS BEFORE USE. THE IFU (LUCEA 10-40 IFU 01701 REV. 11, PAGE 7) MENTIONS THAT THE LUCEA 40 IS A DIAGNOSTIC LAMP INTENDED FOR LOCAL ILLUMINATION OF THE PATIENT'S BODY TO FACILITATE DIAGNOSTIC OR TREATMENT PROCEDURES THAT CAN BE DISCONTINUED WITHOUT RISK TO THE PATIENT IN THE EVENT OF LAMP FAILURE. IT IS NOT INTENDED FOR USE IN THE OPERATING ROOM. 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.

Additional Manufacturer Narrative

THE CORRECTION OF B5 DESCRIPTION EVEN OR PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 18TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE CONTROL BUTTON WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 18TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE CONTROL BUTTON WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. ON 30TH MAY 2022 THE NEW INFORMATION WAS PROVIDED BY GETINGE TECHNICIAN AND IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THE MISSING ON/OFF BUTTON WAS PUSHED INTO THE DEVICE. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

Description of Event or Problem

ON 18TH MAY, 2022 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE CONTROL BUTTON WAS MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. ON 30TH MAY 2022 THE NEW INFORMATION WAS PROVIDED BY GETINGE TECHNICIAN AND IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THE MISSING ON/OFF BUTTON WAS PUSHED INTO THE DEVICE. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.