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

Model Number	ARDPWT629057A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - powerled ii 700.Based on initially described issues, it was not possible to determine if any issue is safety or risk related.On (b)(6) 2025 the getinge technician provided information that the bolts holding the suspension tube/light assembly were not tight so below the ceiling the whole assembly would wobble a little.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, d4 catalog # and h4 device manufacture date deems required.This is based on the internal evaluation.Previous b5 describe event and problem: getinge became aware of an issue with one of surgical lights - powerled ii 700.Based on initially described issues, it was not possible to determine if any issue is safety or risk related.On 28th february 2025 the getinge technician provided information that the bolts holding the suspension tube/light assembly were not tight so below the ceiling the whole assembly would wobble a little.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights - powerled ii.Based on initially described issues, it was not possible to determine if any issue is safety or risk related.On 28th february 2025 the getinge technician provided information that the bolts holding the suspension tube/light assembly were not tight so below the ceiling the whole assembly would wobble a little.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.Previous d4 catalog # ard569237903.Corrected d4 catalog # blank.Previous h4 device manufacture date 05/06/2024.Corrected h4 device manufacture date 07/03/2024.Getinge became aware of an issue with one of surgical lights - powerled ii.Based on initially described issues, it was not possible to determine if any issue is safety or risk related.On 28th february 2025 the getinge technician provided information that the bolts holding the suspension tube/light assembly were not tight so below the ceiling the whole assembly would wobble a little.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and 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 a subject matter expert at the manufacturer¿s site.The configuration is still under warranty and the installation is less than one year.The mechanical connection between the tube and the suspension is held by 6 screws tightened to 50 n.M, which is a very strong torque.Furthermore, these screws are preglued.If they have become loose, the most probable root cause is that they were not tightened properly during installation.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
Getinge became aware of an issue with one of surgical lights - powerled ii.Based on initially described issues, it was not possible to determine if any issue is safety or risk related.On 28th february 2025 the getinge technician provided information that the bolts holding the suspension tube/light assembly were not tight so below the ceiling the whole assembly would wobble a little.There was no injury reported, however, we decided to report the issue in abundance of caution as loose screws holding the device configuration may lead to the device detachment from the ceiling and serious injury.

• 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: 21618659
• Report Number: 9710055-2025-0000099
• Device Sequence Number: 8536184
• Product Code: FTD
• UDI-Device Identifier: 03700712424756
• UDI-Public: (01)03700712424756
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/17/2025

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: ARDPWT629057A
• Device Catalogue Number: ARD569237903
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown