LUCEA 50/100
Report
- Report Number
- 9710055-2023-00893
- Event Type
- Malfunction
- Date Received
- November 20, 2023
- Date of Event
- October 26, 2023
- Report Date
- November 20, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FTD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM, D1 BRAND NAME AND D2A PRODUCT CODE FOR THE FDA DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 26TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS - LUCEA 10/40. IT WAS STATED THE LAMP HOUSING WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT SOME COVER PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 26TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE LAMP HOUSING WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT SOME COVER PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. PREVIOUS D1 BRAND NAME: LUCEA 10/40. CORRECTED D1 BRAND NAME: LUCEA 50/100. PREVIOUS D2A PRODUCT CODE FOR THE FDA: KZF. CORRECTED D2A PRODUCT CODE FOR THE FDA: FTD.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE LAMP HOUSING WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT SOME COVER PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. DEFECTIVE PARTS S/A LOWER COVER WITH FORK - L100 (ARD368614998), L100-SET UPPER COVER + HANDLE SUPPORT (ARD368616555) AND L100 - SET TOP FRAME WITH BRAKE (ARD368640555) WERE REPLACED AND DEVICE WAS BACK TO USAGE. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. CRACKS WERE DETECTED ON THE LIGHT HEAD COVERS, AT THE EDGE OF THE ON/OFF BUTTON. ACCORDING TO THE SUBJECT MATTER EXPERT AT THE MANUFACTURER, THE USER CAN VISUALLY DETECT THE CRACKS DURING THE DAILY CHECKS TO BE PERFORMED PRIOR TO EACH USE, OR DURING PREVENTIVE MAINTENANCE. IN THIS CASE, THE USER WOULD CONTACT A GETINGE REPRESENTATIVE TO REPLACE THE DEFECTIVE COVER OF THE AFFECTED DEVICE (ARD368614998 LOWER COVER WITH FORK). FOR CLEANING, THE USER TO NOT USE AGGRESSIVE AND ABRASIVE PRODUCTS. DURING DISINFECTION, IT IS PROHIBITED TO SPRAY THE DISINFECTANT SOLUTION DIRECTLY ON THE DEVICE AND TO USE INAPPROPRIATE DISINFECTANTS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
ON 26TH OCTOBER, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS - LUCEA 50/100. IT WAS STATED THE LAMP HOUSING WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT SOME COVER PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.
ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EXAMINATION LIGHTS - LUCEA 10/40. IT WAS STATED THE LAMP HOUSING WAS BROKEN. PHOTOGRAPHIC EVIDENCE CONFIRMED THAT ISSUE AND INDICATED THAT SOME COVER PARTICLES WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF DURING EXAMINATION MAY LEAD TO POTENTIAL INFECTION OF THE PATIENT.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272517 | LUCEA 50/100 | LAMP, SURGICAL | FTD | MAQUET SAS | ARD569065999 | ||
| 600861 | LUCEA 50/100 | LAMP, SURGICAL | FTD | MAQUET SAS | ARD569065999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |