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

Model Number	ARDLCA219000A
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On 23rd november, 2023 getinge became aware of an issue with one of our surgical lights - lucea 100.Based on video evidence the connection between spring arm and fork was loose with risk of detachment, also the paint was peeling from the fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field may cause contamination or serious injury.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our surgical lights - lucea 100.Based on video evidence the connection between spring arm and fork was loose with risk of detachment, also the paint was peeling from the fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field may cause contamination or 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.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed.As stated by the subject matter expert, since july 2015, from the serial number (b)(6), by the design change request e140805, the between the fork and the axle is welded with a plug.To validate the design change e140805, a lucea 100, equiped with a welded fork, was tested by tensile and torsion test cre 14-220.The test report cre 14-220, performed according to the standard iec 60601-1 ed.3, mentions that, during tensile and torsion tests, no crack was detected when a 100 n effort was apllied and no fracture was detected when 250 nm was applied.The serial number of light head involved is higher than (b)(6) and correspond to the welded design.The welded connection, between the fork and the axle, of the device involved, probably broke by repetitive and excessive effort > 250 n.The tearing of the welded joint led to paint chipping around the mechanical connection axle/fork.The fork involved must be replaced by ard368614998 including the lower cover.To prevent any incident, the lucea 50-100 instruction for use ifu 01741 en 08, mentions to check the lightheads, during daily inspections before use, for chipped paint and any damage, and to operate the device making several movements to detect any stability issue.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.The correction of d1 brand name, d2 common device name, d4 catalog #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain, h4 device manufacture date and h6 component codes fields deems required.This is based on the internal evaluation.Previous d1 brand name: lucea 100.Corrected d1 brand name: lucea led®.Previous d2 common device name: ftd - lamp, surgical.Corrected d2 common device name: fsy - light, surgical, ceiling mounted.Previous d4 catalog #: ardlca219000a.Corrected d4 catalog #: n/a.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 h4 device manufacture date: 11/10/2016.Corrected h4 device manufacture date: 11/14/2016.Previous h6 component codes: mechanical|coating material||4768.Mechanical|joint||854.Corrected h6 component codes: mechanical|coating material||4768.Mechanical|holder||838.

• 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: 18244408
• Report Number: 9710055-2023-00929
• Device Sequence Number: 14137222
• Product Code: FSY
• UDI-Device Identifier: 03700712400613
• UDI-Public: (01)03700712400613
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 12/01/2023
• 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
• Device Model Number: ARDLCA219000A
• Device Catalogue Number: ARDLCA219000A
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown