MAUDE Adverse Event Report: Maquet SAS STANDOP VOLISTA®; Light, Surgical, Ceiling Mounted

Model Number	ARDVST229039A
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	08/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cesarean section, while adjusting the position of the surgical light, the rear cover detached from the spring arm of the volista standop surgical light due to significant mechanical contact and fell onto the sterile table during the operation, resulting in contamination of the sterile instruments.After re-preparing the sterile instruments, the surgery continued, and the procedure time was extended.The issue was confirmed based on photographic evidence.No patient injury was reported.
Additional Manufacturer Narrative
Event site name: (b)(6).An investigation was conducted regarding the detachment of the rear cover from the spring arm and its fall onto the sterile table.Evaluation of the provided evidence showed detachment consistent with significant mechanical contact during routine operating room handling.No evidence was identified to suggest a manufacturing, material, or design-related defect.The associated risk of particulate generation and potential contamination of the sterile field has been previously identified and assessed within the risk management file, and existing mitigations remain effective.This issue is managed within the manufacturer¿s quality system and monitored through ongoing trending activities.No capa or field action is required at this time.

• Brand Name: STANDOP 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: 50880943
• Report Number: 9710055-2026-0000148
• Device Sequence Number: 9762342
• Product Code: FSY
• UDI-Device Identifier: 03700712401634
• UDI-Public: (01)03700712401634
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: ARDVST229039A
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown