MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number	ARDLCA209012A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was the getinge technician.Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, upon the device inspection one out of the six fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
Additional Manufacturer Narrative
The correction of d4 catalog #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, b5 describe event and problem deems required.This is based on the internal evaluation.Previous d4 catalog # ardlca209012a.Corrected d4 catalog # ard568604998.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.Previous b5 describe event and problem: on 20th february 2023 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, upon the device inspection one out of the six fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Corrected b5 describe event and problem: on 20th february 2023 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, upon the device inspection one out of the four fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, upon the device inspection one out of the four fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.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 the event.The issue was found by the technician during the inspection.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: the lucea suspension fixing screws are 4 x screws 3m¿ fastener adhesive 2510 fhc m6x16 class 10.9.Spare p/n: ard368835555.The 4 screws need to be tightened to a torque of 16 n.M during installation to avoid any loosened screws as described in the lucea installation manual lucea 50-100 ref: 01744 the most probable root cause is insufficient tightening during installation.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
On 20th february 2023 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated, upon the device inspection one out of the four fixation screws holding the device main tube were loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.

• Brand Name: LUCEA 50
• Common Device Name: LAMP, SURGICAL
• 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: 16491731
• Report Number: 9710055-2023-00174
• Device Sequence Number: 20283200
• Product Code: FTD
• UDI-Device Identifier: 03700712400637
• UDI-Public: (01)03700712400637
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/06/2023

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
• Device Catalogue Number: ARD568604998
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown