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

Model Number	ARDVCS209030A
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	07/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights ¿ volista access ii.As it was stated, the keypad has detached from the board and fall into sterile field during procedure.There was no injury reported.
Additional Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (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: 50190649
• Report Number: 9710055-2026-0000140
• Device Sequence Number: 6122535
• Product Code: FSY
• UDI-Device Identifier: 03700712420635
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: ARDVCS209030A
• 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: 07/18/2026
• Initial Report FDA Received Date: 08/10/2026
• Date Device Manufactured: 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown