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

Model Number	ARDPWT209058A
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	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, the connection between the fork and the headlight was found to be loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the headlight may lead to the headlight detachment from the fork and cause serious injury.
Additional Manufacturer Narrative
The initial reporter was a biomedical technician.Event site name: (b)(6), event site address: (b)(6).Additional information will be provided following the conclusion of the investigation.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, the connection between the fork and the headlight was found to be loose.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the headlight may lead to the headlight detachment from the fork and cause 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.It is unknown if the claimed device was or was not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s site.The hub fixing screws inside the fork are pre-glued and are tightened at the torque of 4.1 nm using the gdc71023 tool.This is the first case recorded about similar troubles.One thing has been tested in a production line, if these screws are not tightened completely during assembly (even 1mm), it is detected easily by operators.Hence, so far this case remains unexplained.This is an isolated case.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 ot (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: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 23278190
• Report Number: 9710055-2025-0000268
• Device Sequence Number: 5519316
• Product Code: FTD
• UDI-Device Identifier: 03700712407681
• UDI-Public: (01)03700712407681
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/13/2025

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
• Operator of Device: Health Professional
• Device Model Number: ARDPWT209058A
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown