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

Model Number	ARDLCA209012A
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6) event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 26th march, 2024 getinge became aware of an issue with one of surgical lights - lucea 50.It was stated the cap on the spring arm was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
Event or Problem Description
On 26th march, 2024 getinge became aware of an issue with one of surgical lights - lucea 50.During maintenance it was found the cap on the spring arm was missing and the label was chipping.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, d1 brand name, d2a product code, previous d2b product code description, d4 catalog #, d4 unique identifier (udi) # and h4 manufacture date deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th march, 2024 getinge became aware of an issue with one of surgical lights - lucea 50.During maintenance it was found the cap on the spring arm was missing.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 26th march, 2024 getinge became aware of an issue with one of surgical lights - lucea 50.During maintenance it was found the cap on the spring arm was missing and the label was chipping.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Previous d1 brand name: lucea 50/100.Corrected d1 brand name: lucea led®.Previous d2a product code: ftd.Corrected d2a product code: fsy.Previous d2b product code description.: lamp, surgical.Corrected d2b product code description.: light, surgical, ceiling mounted.Previous d4 catalog # ardlca209012a.Corrected d4 catalog # none.Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h4 manufacture date: 2019-07-10.Corrected h4 manufacture date: 2019-07-11.Getinge became aware of an issue with one of surgical lights - lucea 50.During maintenance it was found the cap on the spring arm was missing and the label was chipping.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.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 claimed device was not being used for patient treatment or diagnosis when the event took place.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 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.We strongly advise to check similar devices in the hospital 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.Label peeling is probably due to collision or repeated excessive rubbing during cleaning of the device, the use of aggressive or unsuitable cleaning agents may be a contributing factor.The user manual mentions to check the lightheads for chipped paint, impact marks and any other damages during daily checks.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• 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: 18996306
• Report Number: 9710055-2024-00233
• Device Sequence Number: 2946408
• Product Code: FSY
• UDI-Device Identifier: 03700712400637
• UDI-Public: (01)03700712400637
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K113679
• 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): 03/28/2024

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: ARDLCA209012A
• Device Catalogue Number: ARDLCA209012A
• 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: 03/26/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown