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

Model Number	ARDVCS209004A
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	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site name: (b)(6).Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Getinge became aware of an issue with volista access surgical light.As it was stated, the circlip was deformed.There was no injury reported, however, we decided to report the issue in abundance of caution as the problem with circlip may cause detachment of parts, and it can lead to serious injury or worse.
Additional Manufacturer Narrative
Getinge became aware of an issue with volista access surgical light.As it was stated, the circlip was deformed.There was no injury reported, however, we decided to report the issue in abundance of caution as the problem with circlip may cause detachment of parts, and it can lead to serious injury or worse.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 does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.As stated by the subject matter expert, the mechanical coupling between the spring arm and the main arm has failed because the circlip was not fully seated in its groove.The root cause is an incorrect fitting during installation or spring arm replacement for maintenance.All the procedure and reminders about the correct fitting of this circlip are detailed in all installation manuals lights where it is involved.This mounting is a critical operation and must be performed according to the rules.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 ACCESS
• 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: 21101724
• Report Number: 9710055-2025-0000003
• Device Sequence Number: 15612638
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: (01)03700712401320
• 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): 01/08/2025

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: ARDVCS209004A
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown