MAUDE Adverse Event Report: MAQUET SAS LUCEA LED®; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDLCA209012A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, paint damage was found on the device.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping from the spring arm.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 in case of reoccurrence.
Event or Problem Description
Manufacturer's reference number (b)(6).
Additional Manufacturer Narrative
Initial reporter: getinge technician.Getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, paint damage was found on the device.The designated complaint unit employee confirmed based on photographic evidence the paint was chipping from the spring arm.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 in case of reoccurrence.The device has been repaired by replacement of spring arm for lca 50 (ard568604941) and returned to use.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.The claimed device was not being used for patient treatment or diagnosis when the event took place.After receiving the defective parts, our quality control department conducted a scratch test on the paint.The result confirmed a paint adhesion defect.The two defective parts were sent to the supplier for analysis.The supplier received the parts in early may 2025.The scratch test indeed revealed a paint adhesion defect on the two incriminated parts.However, the scratch test on the other two parts confirmed good paint adhesion, thus securing this batch.This allowed us to pinpoint the issue to the batch of parts delivered in march 2024 from order maquet (b)(4).He also checked the paint thickness on the parts.The measured thickness is above the maximum allowed tolerance, which is 110 m.This excess thickness could therefore explain the poor paint adhesion on these parts.After some research by the supplier on internal non-conformities concerning this batch of parts, he confirmed an internal non-conformity affecting 11 parts due to contamination.These parts were repainted, but apparently, they were overloaded with paint.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: LUCEA LED®
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 20829382
• Report Number: 9710055-2024-0000609
• Device Sequence Number: 4032369
• Product Code: FSY
• UDI-Device Identifier: 03700712400637
• UDI-Public: (01)03700712400637
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA209012A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown