MAUDE Adverse Event Report: MAQUET SAS MAQUET EQUIPMENT; HOLDER, CAMERA, SURGICAL

Model Number	ARDSAT239019A
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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site telephone: (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 light - eqt.As it was stated, spring arm cover detached from the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause serious injury.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical light - eqt.As it was stated, spring arm cover detached from the device.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may 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.Provided information indicate if upon the event occurrence, the device was not being used for patient treatment.Root cause analysis was performed by subject matter expert at manufacturer¿s, the analysis is following.During daily check of the xhs0 screen holder, it was discovered that the side cover of the ard567801151 spring arm was detached.No broken parts or anomalies in the assembly were reported.No fall was reported.The cause of the detachment is probably a gradual loosening or the absence of one of the cover fixing screws.Based on that the specific root cause cannot be determined.To prevent any incident the instruction for use ifu 01821 mentions to check, during daily visual and functional inspections, that the spring arm covers are in the proper position and in good condition.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 EQUIPMENT
• Common Device Name: HOLDER, CAMERA, 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: 23876021
• Report Number: 9710055-2025-0000315
• Device Sequence Number: 4706248
• Product Code: FXR
• UDI-Device Identifier: 03700712416096
• UDI-Public: (01)03700712416096
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: ARDSAT239019A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown