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

Model Number	ARDVCS209015A
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	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We were informed of the incident by the hospital's clinical engineer.Phone number: (b)(6).Getinge became aware of an issue with one of surgical lights - volista access.Customer reported that a screw in the spotlight's structure fell out during a surgical procedure, and that the screw fell onto the patient.The patient was not harmed by the incident.The screw was retightened to ensure its fixation.The screw is placed in the spring arm and holds the safety ring and the spotlight dome.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since detachment of the screw from spring arm cover could be considered as technical deficiencies, and in this way the device contributed to event.A root cause analysis was performed by subject matter experts at the manufacturing site.As they stated it was detected that the screw on the spring arm cover detached.This screw is responsible for attaching the cover to the spring arm structure.The manufacturer of the spring arms, ¿ondal¿, led several tests on a spring arm performing 20.000 cycles of up and down movement.The test with a loosened screw, with a complete turn back, shows that it is the only case where the screw continue to loosen.Based on the analysis of the cases reported, several cases were detected, all delivered in the same hospital, on a period less than 1 year after the installation, the other cases were detected more than 1 year after the installation.The cases detected after more than 1 year after the installation correspond to a lack of inspection during the yearly preventive maintenance.To prevent the loosening and the fall of the screw, the technical manuals indicate to check all the fixing screws and to check the hold of the spring arm covers during yearly preventive maintenance or daily inspections.The screw has a long threading, its loosening is visually detectable during cleaning or during yearly preventive maintenance.As improvement measure, since october 2019, the spring arms covers are assembled, on the product line, with tuflok coated screws.In any case, by design, the nylon patch of this screw acts as a mechanical locking and prevents the loosening and the fall of the screw.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
Getinge became aware of an issue with one of surgical lights - volista access.Customer reported that a screw in the spotlight's structure fell out during a surgical procedure, and that the screw fell onto the patient.The patient was not harmed by the incident.The screw was retightened to ensure its fixation.The screw is placed in the spring arm and holds the safety ring and the spotlight dome.We decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

• 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: 22736481
• Report Number: 9710055-2025-0000200
• Device Sequence Number: 12562381
• Product Code: FSY
• UDI-Device Identifier: 03700712420475
• UDI-Public: (01)03700712420475
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/07/2025

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: ARDVCS209015A
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown