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

Model Number	ARDVCS209030A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
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 that the cover on the spring arm had cracked.Designated complaint unit employee confirmed reported issue based on photographic evidence.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.
Event or Problem Description
Manufacturer's reference number ot#(b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that the cover on the spring arm had cracked.Designated complaint unit employee confirmed reported issue based on photographic evidence.There was no injury reported, however we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination.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.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.Root cause analysis was performed by subject matter expert at manufacturer¿s.The analysis is following: residues from cleaning agents can adversely affect plastic components, potentially causing their degradation.Factors such as the concentration of chemical substances and the presence of leftover disinfectants on surfaces are likely contributors to material deterioration.Physical damage to the dust cover may also result from contact with other components, such as the spring arm or light head.The most likely cause of damage to the dust cover is collision with other products and/or an inappropriate cleaning product or protocol.The user manual also recommends performing daily inspections to identify any signs of damage, including paint chips, impact marks, or other visible defects.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• Brand Name: VOLISTA ACCESS II
• 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: 21616543
• Report Number: 9710055-2025-0000098
• Device Sequence Number: 6687001
• Product Code: FSY
• UDI-Device Identifier: 03700712420635
• UDI-Public: (01)03700712420635
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/14/2025

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: ARDVCS209030A
• Device Catalogue Number: ARD568806906
• 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: 05/06/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown