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

Model Number	ARDPWT659156A
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	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled ii.It was stated and confirmed by photographic evidence there was a gap between spring arm and suspension arm.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
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights, powerled ii.It was stated and confirmed by photographic evidence there was a gap between spring arm and suspension arm.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination.Based on information gathered, the device has been repaired.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.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.Root cause analysis was performed by subject matter expert at the manufacturer.As they stated, root cause analysis indicates that the separation between the suspension and the spring arm resulted from the circlip being removed due to incorrect assembly.The installation manual includes all instructions related to the positioning of the circlip.The service protocol indicates that the circlips must be checked by visual inspection.To prevent any similar incident maquet recommends respecting the installation instructions.Getinge shall continue to monitor for any further events of this nature and do 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: 23670220
• Report Number: 9710055-2025-0000303
• Device Sequence Number: 21293694
• Product Code: FTD
• UDI-Device Identifier: 03700712429652
• UDI-Public: (01)03700712429652
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/28/2025

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
• Device Model Number: ARDPWT659156A
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown