LUCEA 10

Description of Event or Problem

ON 15TH MARCH 2022, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 10. THE RECEIVED CUSTOMER ALLEGATION REGARDED A NON REPORTABLE ISSUE. ON 5TH APRIL 2022 TECHNICIAN BECAME AWARE OF REPORTABLE ISSUES - COVER WAS CRACKED AND SOME PARTICLES, UNDERSIDE COVER AND HANDLE INTERFACE WERE MISSING OR DETACHED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE.

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'R REFERENCE NUMBER (B)(4).

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS ¿ LUCEA 10. THE RECEIVED CUSTOMER ALLEGATION REGARDED A NON REPORTABLE ISSUE. ON 5TH APRIL 2022 TECHNICIAN BECAME AWARE OF ISSUES CONSIDERED REPORTABLE - HEADLIGHT¿S COVER CRACKED WITH MISSING PARTICLES FROM THIS COMPONENT AND THE DETACHMENT OF THE HEADLIGHT¿S COVER. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS OR PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY IN CASE OF EVENT REOCCURRENCE. ACCORDING TO INFORMATION PROVIDED BY GETINGE TECHNICIAN, THE AFFECTED DEVICE WAS REPAIRED AND RETURNED TO USE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, SURGICAL LIGHTS DID NOT MEET THEIR SPECIFICATION, SINCE CRACKS IN COVERS, RESULTING IN MISSING PLASTIC PARTICLES OR DETACHMENT OF THE COVER 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 MODERATE RATIO FOR THE BROKEN COVERS. 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 ROOT CAUSE OF THE MALFUNCTION IT IS RELATED TO A COLLISION WITH ANOTHER DEVICE, THEREFORE HAS BEEN CLASSIFIED AS "MISUSE". IT IS WORTH HIGHLIGHTING THAT THE USER IS REMINDED TO CHECK IF THE DEVICE SUFFERED FROM ANY IMPACT DAMAGE (IFU 01701 EN 11, PAGE 21). 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.