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

Model Number	ARDVCS209030A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter was the getinge technician.Event site name: (b)(6) hospital.Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with one of its surgical lights ¿ the volista access ii.An employee from the designated complaint unit noticed the presence of paint chipping on the support arm, spring arm, and fork.No injuries have been reported, however we decided to report this issue out of an abundance of caution, as any particles falling into the sterile field or during a procedure could cause contamination in the event of recurrence.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of its surgical lights - the volista access ii.An employee from the designated complaint unit noticed the presence of paint chipping on the support arm, spring arm, and fork.No injuries have been reported, however we decided to report this issue out of an abundance of caution, as any particles falling into the sterile field or during a procedure could cause contamination in the event of recurrence.Based on the information collected, it was established that when the event occurred, the surgical lights did not meet its specification, since paint chipping could be considered as technical deficiencies, and in this way the device contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.As stated by the subject matter expert, peeling paint was probably caused by: a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol.The presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use, the relative humidity must be between 20% and 75%.To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages.The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.To reduce the appearance of degradation of the surface, the technical manual or maintenance manual mentions in the preventive maintenance protocol to lubricate some parts of device.The instruction for use mentions not to use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.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: diana gutekunst ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 23321090
• Report Number: 9710055-2025-0000274
• Device Sequence Number: 13414949
• Product Code: FSY
• UDI-Device Identifier: 03700712420635
• UDI-Public: (01)03700712420635
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 10/17/2025

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: ARDVCS209030A
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown