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 serial #, h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain deems required.This is based on the internal evaluation.Previous d4 serial # (b)(6).Corrected d4 serial # (b)(6).Previous h3a device evaluated by mfg: no.Corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: none.Previous h3c if other provide code-explain: device not returned to manufacturer corrected h3c if other provide code-explain: none.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.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.According to the information gathered, the issue was discovered during inspection by getinge.A root cause analysis was conducted by the subject matter expert.According to the analysis there are two probable scenarios.In case of loosening, the probable causes of loosening corresponds to an improper initial tightening during the installation or maintenance not in accordance with the manufacturer's recommendations.In case of rupture, the failure of the screws is related to fatigue stresses due to moderate shear overload.All facies have a fatigue failure zone more or less extensive.Initiated at the bottom of the thread, the repeated low mechanical stresses caused the breakage of the first screw.The rupture of the other screws corresponds to progressive propagation of the shear effect.To prevent any incident the yearly preventive maintenance program, mentions to check the suspension fixing screws.It is also indicated to not retighten the screws during maintenance.If screws appear loosened, replace them.It is also stated to replace the 6 fixing screws every 6 years.In april 2019 getinge transmitted the service bulletin 98a on getinge online reminding to carry out preventive maintenance and wearing parts replacement to ensure the device safety, the service bulletin 98a mentions to replace the suspension fixing screws every 6 years during the preventive maintenance.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
Manufacturer's reference number (b)(4).

• 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: 16494689
• Report Number: 9710055-2023-00179
• Device Sequence Number: 12396111
• Product Code: FTD
• UDI-Device Identifier: 03700712400637
• UDI-Public: 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): 03/07/2023

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: 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: 02/20/2023
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 07/20/2024
• 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