MAUDE Adverse Event Report: MAQUET SAS LUCEA DUO 100; LAMP, SURGICAL

Model Number	ARDLCA219001A
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 4th september, 2023 getinge became aware of an issue with one of surgical lights - lucea duo 100.Initially, it was not possible to determine if the issue is safety and risk related.Then, after the visit of technician in the facility that took place on 18th september 2023, we received photos and more information about the affected device.Based on additional input from getinge employee and photographic evidence the covers of domes were cracked with missing particles.It was stated by technician that no collision points were found to prove improper use and the several damages are possibly dilatation of the material.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.
Additional Manufacturer Narrative
The correction of h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain fields deems required.This is based on the internal evaluation.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.On 4th september, 2023 getinge became aware of an issue with one of surgical lights - lucea duo 100.Initially, it was not possible to determine if the issue is safety and risk related.Then, after the visit of technician in the facility that took place on 18th september 2023, we received photos and more information about the affected device.Based on additional input from getinge employee and photographic evidence the covers of domes were cracked with missing particles.It was stated by technician that no collision points were found to prove improper use and the several damages are possibly dilatation of the material.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination or serious injury.Defective part s/a lower cover with fork - l100 (ard368614998) was replaced.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the cracked cover, leading to missing plastic particles could be considered a technical deficiency, and in this way the device contributed to the event the device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered by a clinical engineering technician.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to the subject matter expert at the manufacturer, the user can visually detect the cracks during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective cover of the affected device (ard368614998 lower cover with fork).For cleaning, the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and to use inappropriate disinfectants.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).

• Brand Name: LUCEA DUO 100
• 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: 17787581
• Report Number: 9710055-2023-00716
• Device Sequence Number: 7472747
• Product Code: FTD
• UDI-Device Identifier: 03700712402563
• UDI-Public: (01)03700712402563
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

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: ARDLCA219001A
• Device Catalogue Number: ARDLCA219001A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown