LUCEA 10
Received May 19, 2022 · Event occurred Mar 22, 2022
Report 9710055-2022-00156 · MDR key 14434022
Device
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 22ND 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. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE TAKEN ON (B)(6) 2022, COVER WAS CRACKED AND SOME PARTICLES AND UNDERSIDE COVER WERE MISSING. 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'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.
Description of Event or Problem
ON 22ND 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. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE TAKEN ON 5TH APRIL 2022, COVER WAS CRACKED AND SOME PARTICLES AND UNDERSIDE COVER WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.
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. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE TAKEN ON 5TH APRIL 2022, COVER WAS CRACKED AND SOME PARTICLES AND UNDERSIDE COVER WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. 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 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. WE HAVE BEEN ABLE TO CONFIRM THAT THE INVESTIGATED ISSUE HAS NEVER LED TO SERIOUS INJURY OR WORSE, TO OUR KNOWLEDGE. 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 LUCEA10/40 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 LIGHT HEADS. THIS DOCUMENT INCLUDES SOME RECOMMENDED PRODUCTS AND SOME PROHIBITED PRODUCTS. IN ORDER TO AVOID TORQUES APPLIED ON THE TRANSPARENT HOUSING DURING USE THE LUCEA10/40 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. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 22ND 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. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE TAKEN ON 5TH APRIL 2022, COVER WAS CRACKED AND SOME PARTICLES AND UNDERSIDE COVER WERE MISSING. 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. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 22ND 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. ACCORDING TO THE PHOTOGRAPHIC EVIDENCE TAKEN ON 5TH APRIL 2022, COVER WAS CRACKED AND SOME PARTICLES AND UNDERSIDE COVER WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY DETACHMENT OF PART OR PARTICLES MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.