MAUDE Adverse Event Report: Maquet SAS Volista; Light, Surgical, Ceiling Mounted

Model Number	ARDVST639011A
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
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista standop.It was stated that the light was not working prior to use.During the inspection, it was noted that the snap ring securing the spring arm bushing had come loose.No harm to the patient or operator was reported.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.

• Brand Name: Volista
• 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: 50472420
• Report Number: 9710055-2026-0000143
• Device Sequence Number: 13311486
• Product Code: FSY
• UDI-Device Identifier: 03700712433161
• UDI-Public: (01)03700712433161
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: ARDVST639011A
• 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: 08/01/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown