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

Model Number	ARDVCS209032A
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	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the surgical lights - volista access ii.It was reported that the keypads fell off during surgery.The fault did not cause any patient harm or delays in interventional procedures.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
Getinge became aware of an issue with one of the surgical lights - volista access ii.It was reported that the keypads fell off during surgery.The fault did not cause any patient harm or delays in interventional procedures.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.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 that upon the event occurrence, the device was being used for patient treatment.Root cause analysis was performed by a subject matter expert at the manufacturer¿s, the volista access ii headlight¿s keypad foil detached and dropped.The root cause of the front panel detachment in the capacitive keyboard to the pcb lies in the adhesive choice implemented during the product design stage.A design change (ecr-241203) has been initiated in order to improve the keypad adherence to the pcb.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: 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: 23777339
• Report Number: 9710055-2025-0000310
• Device Sequence Number: 9933870
• Product Code: FSY
• UDI-Device Identifier: 03700712420659
• UDI-Public: (01)03700712420659
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/11/2025

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: ARDVCS209032A
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown