MAUDE Adverse Event Report: MAQUET SAS MAQUET POWERLED II; LAMP, SURGICAL

Model Number	ARDPWT679062A
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	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue involving one of the surgical lights ¿ powerled ii.It was reported that the connection between the suspension arm and the main tube was found to be loose due to the lack of a circlip.No injuries were reported; however, we decided to report the issue out of an abundance of caution, as a loose suspension arm may lead to detachment of the device from the ceiling and could result in serious injury.
Additional Manufacturer Narrative
Getinge became aware of an issue involving one of the surgical lights - powerled ii.It was reported that the connection between the suspension arm and the main tube was found to be loose due to the lack of a circlip.No injuries were reported; however, we decided to report the issue out of an abundance of caution, as a loose suspension arm may lead to detachment of the device from the ceiling and could result in serious injury.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.According to the information received by getinge, the issue occurred during surgery.Root cause analysis was performed by subject matter expert at the manufacturer.As they stated, the internal investigations were conducted by the quality and methods department to identify the causes of the absence of the circlip on the suspension shaft.Their conclusion is: the control bench and its detection fixture verify the presence of the circlip and safety screw.If either is missing, the system alerts the operator and blocks further testing.The product cannot be approved or shipped until all required checks are completed.Additional information received from the us subsidiary on 6 february 2026 indicates that the product had not been displaced or dismantled since installation.No service activities, including repairs or maintenance, had been performed by getinge on this equipment since its installation.During inspection, no snap ring or any remnants of a broken snap ring were found.Based on the investigation, the specific cause of the missing circlip could not be conclusively determined.Several scenarios remain possible, such as voluntary removal of the component, interference during storage, or interference shortly before the incident, including during use by a third party.It should be noted that no similar occurrences have been previously reported within the sa-sax product range, which supports the conclusion that this event is isolated based on historical quality data.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: MAQUET POWERLED II
• 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: sylviane boiron bourgeois ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 24312470
• Report Number: 9710055-2026-0000027
• Device Sequence Number: 5650583
• Product Code: FTD
• UDI-Device Identifier: 03700712431372
• UDI-Public: (01)03700712431372
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: ARDPWT679062A
• Device Catalogue Number: ARDPWT679062A
• 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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown