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

Model Number	ARDVCS209031A
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	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that the support of the keypad had come loose.The keypad fell onto the surgical field fabric during an intervention.No harm to the patient or operator was reported.
Additional Manufacturer Narrative
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: 50880957
• Report Number: 9710055-2026-0000149
• Device Sequence Number: 9782674
• Product Code: FSY
• UDI-Device Identifier: 03700712420642
• UDI-Public: (01)03700712420642
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: ARDVCS209031A
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown