MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS; LIGHT, SURGICAL, CEILING MOUNTED

Model Number	ARDVCS209007A
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	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access.Upon inspection, the mechanical damage of headlight was identified, which caused to its detachment from the arm.The headlight remained suspended by the internal cables, preventing it from falling completely.The issue was confirmed by photographic evidence.There was no injury reported, however we decided to report the issue out of an abundance of caution, as any component falling into the sterile field or during a procedure may cause contamination or injury.
Additional Manufacturer Narrative
Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number ot#(b)(4).
Additional Manufacturer Narrative
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 a subject matter expert at the manufacturer¿s, based on analysis and provided evidence it can be confirmed that: - all three screws are present and properly tightened - the red marking on the screws indicates that they are pre-coated with adhesive.- all three washers are present therefore this failure was most likely caused by excessive mechanical stress applied to the light head or by a significant impact when the light head was in its lower position.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: VOLISTA ACCESS
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• 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: 24752692
• Report Number: 9710055-2026-0000056
• Device Sequence Number: 18676744
• Product Code: FSY
• UDI-Device Identifier: 03700712401351
• UDI-Public: (01)03700712401351
• Combination Product (Y/N): N
• 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): 04/01/2026

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: ARDVCS209007A
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown