MAUDE Adverse Event Report: MAQUET SAS LUCEA 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)
Date of Event	10/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1b event site name: kalinga institute of medical e1h event site postal code: (b)(6).E1i event site telephone: (b)(6).H3 other text : device not returned to manufacturer.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our surgical lights ¿ lucea 100/100.As it was stated and confirmed with the photographic evidence, the headlight covers on both domes were cracked with missing particles.The issue was discovered during daily check up.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our surgical lights ¿ lucea 100/100.As it was stated and confirmed with the photographic evidence, the headlight covers on both domes were cracked with missing particles.The issue was discovered during daily check up.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Defective parts s/a lower cover with fork - l100 (ard368614998) and l100-set upper cover + handle support (ard368616555) were replaced and device back to usage.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.The device was not being used for patient treatment upon the event occurrence.According to the information gathered, the issue was discovered during daily check.As stated by the subject matter expert at manufacturing site, cracks located on the light head lower covers, at the edge of the on/off button, were detected during daily visual inspection, as recommended by the user manual.If the described failure occurs, the user can visually detect it 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 covers of the affected device.For cleaning, the ifu informs 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.To prevent any incident the lucea 50-100 user manual mentions: ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections.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 h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code - explain and h4 manufacture date 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.Previous h4 manufacture date: 06/05/2018.Corrected h4 manufacture date: 06/07/2018.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: LUCEA 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: 18055426
• Report Number: 9710055-2023-00838
• Device Sequence Number: 20311850
• Product Code: FTD
• UDI-Device Identifier: 03700712400651
• UDI-Public: (01)03700712400651
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/02/2023

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
• Operator of Device: Health Professional
• 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: 10/28/2023
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 07/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown