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

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	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was customer.The correction of d1 brand name, d2 product code, d2 product code description, d4 version or model # and d4 unique identifier (udi) # deems required.This is based on the internal evaluation.Previous d1 brand name: lucea 50 corrected d1 brand name: lucea led®.Previous d2 product code.: ftd.Corrected d2 product code.: fsy.Previous d2 product code description.: lamp, surgical.Corrected d2 product code description.: light, surgical, ceiling mounted.Previous d4 version or model # : ard569010102.Corrected d4 version or model # : ardlca209012a.Previous d4 catalog # : ard569010102.Corrected d4 catalog # : none.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated the cover detached from the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.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.As stated by subject matter expert at maquet sas, the most probable root cause of the break of this cap is repeated and violent shocks during the use of the device.Another probable root cause is that the cap has been forgotten or deteriorated after a readjustment of the spring arm during the maintenance of medical device.The yearly preventive maintenance program documented in the technical manual for lucea 10/40 (0170201 1k) on page 10 mentions to check the fixing of all caps.The cap must be reinstalled during installation or after the maintenance procedure.Maquet sas strongly advises to check similar devices in the hospital in order to check the presence of all spring arms caps.If a missing cap is noticed, a new one should be ordered as spare parts.(blue 30 / lucea 40-50 : ard569010102) getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Contact person phone number: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - lucea 50.As it was stated the cover detached from the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination in case of reoccurrence.

• 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: 19678132
• Report Number: 9710055-2024-00406
• Device Sequence Number: 18004344
• Product Code: FSY
• 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): 07/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ARDLCA209012A
• Device Catalogue Number: ARD569010102
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown