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

Model Number	ARDPWT609009A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Getinge became aware of an issue involving one of the surgical lights ¿ maquet powerled ii.It was reported that the black plastic cover detached from the dome arm and fell into the patient's abdomen, where it came into contact with the aortic prosthesis being implanted.The patient received prophylactic antibiotic treatment with cefazolin (2 g intravenously at h0, followed by 1 g intravenously every 4 hours) and remains under clinical and biological monitoring after the surgery.We decided to report this issue as the described outcome is consider to meet the definition of a serious injury.
Additional Manufacturer Narrative
Event site name: (b)(4) additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
The correction of d4 catalog# deems required.This is based on the internal evaluation.Previous d4 catalog#: ardpwt609009a.Corrected d4 catalog#: getinge became aware of an issue involving one of the surgical lights ¿ powerled ii.It was reported that the black plastic cover detached from the fork and fell into the patient's abdomen, where it came into contact with the aortic prosthesis being implanted.The patient received prophylactic antibiotic treatment with cefazolin (2 g intravenously at h0, followed by 1 g intravenously every 4 hours) and remains under clinical and biological monitoring after the surgery.The outcome as described is consider meeting the definition of a 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 experts at the manufacturer.As they stated, the cleaning of the device, and particularly the wiping of the device may lead to a partial dismantling of the silicone cap.This partial dismantling may lead to a fall of the silicone cap during the cleaning, or during a surgical procedure.To prevent any incident, the powerledii and volista instruction for use ifu 01811 & 01781 instruction mentions: - do not use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.- check the proper position caps and cover during the daily inspections before use.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• 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: 24699328
• Report Number: 3013876692-2026-00048
• Device Sequence Number: 15979901
• Product Code: FTD
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026
• Report Date (Section F): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: ARDPWT609009A
• Device Catalogue Number: ARDPWT609009A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Date Report to Manufacturer: 05/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 193 LB
• Date Report Sent to FDA: 05/15/2026