MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LIGHT, SURGICAL, FLOOR STANDING

Model Number	ARDLCA219000A
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	08/07/2023
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 (b)(6)2023 getinge became aware of an issue with one of surgical lights - lucea 100.It was stated the cover was missing.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 or serious injury.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - lucea 100.Based on photographic evidence the cap at the side of the spring arm was missing.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 or serious injury.Based on an information provided by getinge technician, defective spring arm ergodisk cap ral9016 (ard569010100) and s/a lower cover with fork - l100 (ard368614998) were replaced and unit was released to use.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the missing cap 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 getinge technician during service intervention.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.As stated by the subject matter expert, 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 re-adjustment of the spring arm during the maintenance of a medical device.The yearly preventive maintenance program documented in the technical manuals mentions to check the presence and fixing of the plastic covers.The cap must be reinstalled during installation or after the maintenance procedure.Maquet sas strongly advises to check similar devices present at the customer site 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 (reference: (b)(4).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.The correction of b5 describe event or problem, h4 manufacture date and h6 component codes fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 7th august, 2023 getinge became aware of an issue with one of surgical lights - lucea 100.It was stated the cover was missing.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 or serious injury.Corrected b5 describe event or problem: on 7th august 2023 getinge became aware of an issue with one of surgical lights - lucea 100.Based on photographic evidence the cap at the side of the spring arm was missing.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 previous h4 manufacture date: 2016-11-10.Corrected h4 manufacture date: 2016-11-14.Previous h6 component codes: mechanical|cover||772.Corrected h6 component codes: mechanical|cap||424.
Event or Problem Description
On 7th august 2023 getinge became aware of an issue with one of surgical lights - lucea 100.Based on photographic evidence the cap at the side of the spring arm was missing.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.

• Brand Name: LUCEA 100
• 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: 17675436
• Report Number: 9710055-2023-00618
• Device Sequence Number: 20677661
• Product Code: FSS
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2023

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: ARDLCA219000A
• Device Catalogue Number: ARDLCA219000A
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 09/04/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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