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

Model Number	ARDVCS209023A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the device was drifting down and reached the patient.The light head falls on the lower part of the patient¿s body.There was no injury reported, however, we decided to report the issue in abundance of caution as it could lead to serious injury in case of reoccurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the device was drifting down and reached the patient.The light head falls on the lower part of the patient¿s body.There was no injury reported, however, we decided to report the issue in abundance of caution as it could lead to serious injury in case of reoccurrence.Based on the information collected, it was established that when the event occurred, the surgical equipment did not meet its specification and in this way the device contributed to event.Provided information indicate that when the event occurred, the device was being used for patient treatment.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: a drift of the lighthead was observed, most likely caused by wear and tear of the brake screw.To prevent any incident, the volista user manual recommends performing daily functionality checks.These include moving the suspension arms, spring arms, and lightheads to ensure smooth operation, and verifying that the system remains stable in the selected position without any drifting.If instability or movement is detected, technical support should be contacted immediately.The installation manual notes that it is normal for brake components to require readjustment within two to six months of initial use, as a result of natural wear.Failure to carry out proper or timely adjustments may lead to unintended movement of the lighthead or other attached elements, increasing the risk of equipment damage.Therefore, all necessary settings ¿ including balance, stops, and brakes ¿ must be correctly adjusted during installation and reviewed after each maintenance intervention.Additionally, the maintenance manual specifies that all brake screws should be replaced annually to ensure continued safe operation and system stability.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 ot# (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: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 21676722
• Report Number: 9710055-2025-0000105
• Device Sequence Number: 12839813
• Product Code: FSY
• UDI-Device Identifier: 03700712420567
• UDI-Public: (01)03700712420567
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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
• Device Model Number: ARDVCS209023A
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown