MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LIGHT, SURGICAL, FLOOR STANDING

Model Number	ARDLCA309004A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.
Event or Problem Description
On 17th february 2023 getinge became aware of a non-reportable issue with one of our surgical lights - lucea 50.On 13th march 2023, service technician arrived on site and detected reportable issue.According to photographic evidence, the paint was damaged on the spring arm and particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Getinge became aware of a non-reportable issue with one of our surgical lights - lucea 50 mobile.On (b)(6) 2023, service technician arrived on site and detected reportable issue.According to photographic evidence, the paint was damaged on the spring arm and particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.It was established that when the event occurred, the surgical light did not meet their specifications due to paint chipping which contributed to the event.Based on available information we were able to indicate that upon the event occurrence the device was not being used for patient treatment.When reviewing similar reportable events for the same device type, it was confirmed that in the last 5 years, registered for the issue of paint peeling on lucea 50/100 surgical lights, there was no event which led to the serious injury and it was related to paint chipping problem.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the investigated issues related to the paint peeling is very low.A root cause analysis for paint peeling problem was also performed by subject matter experts at the manufacturing site, who concluded that: all maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The most probable root cause of this paintwork damage is the collision between other products such as the spring arm or headlight.Moreover, the paintwork damages are most of the time located on the articulations of arms and spring arms.The paint chip or paint damages are due to: impacts or collisions (abnormal use).The operating manual (lucea 50-100 ifu 01741 rev.10, pages 32-36) includes the instructions to pre-position the arms prior to use, in order to prevent damages.Correctly positioning the light before each operation will limit the chances of it coming into contact with other objects.To prevent any similar incident, it is recommended to avoid collisions between devices (lucea 50-100 ifu 01741 rev.10, page 32).Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor paint chip can be repaired with touch up paint, nevertheless, the parts impacted by serious damage must be replaced.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.Initial reporter: (b)(6).
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: LUCEA 50
• Common Device Name: LIGHT, SURGICAL, FLOOR STANDING
• 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: 16563319
• Report Number: 9710055-2023-00218
• Device Sequence Number: 5497876
• Product Code: FSS
• UDI-Device Identifier: 03700712400736
• UDI-Public: (01)03700712400736
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 03/17/2023

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: Other
• Device Model Number: ARDLCA309004A
• Device Catalogue Number: ARDLCA309004A
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown