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	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access.It is observed that the metal structure (clinical infrastructure) where the anchor is and where the suspension tube and the arms and satellites of the lamp are installed oscillate with clockwise and counterclockwise movements and the vertical level of the suspension tube is not constant during the turns, giving the sensation of instability of the lamp and without vertical level.There was no injury reported, however, we decided to report the issue in abundance of caution as loose connection between main tube and suspension arm could lead to fall of whole configuration and as a result of that, could lead to serious injury.
Additional Manufacturer Narrative
Event site telephone: (b)(6).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.Uninitied device movement has been observed due to not constant vertical level of suspension tube.Institution's non-compliance with the project specifications was noticed.There was no injury reported, however, we decided to report the issue in abundance of caution as non-compliance facility could lead to fall of whole configuration and as a result of that, could lead to serious injury.
Additional Manufacturer Narrative
The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: getinge became aware of an issue with one of surgical lights - volista access.It is observed that the metal structure (clinical infrastructure) where the anchor is and where the suspension tube and the arms and satellites of the lamp are installed oscillate with clockwise and counterclockwise movements and the vertical level of the suspension tube is not constant during the turns, giving the sensation of instability of the lamp and without vertical level.There was no injury reported, however, we decided to report the issue in abundance of caution as loose connection between main tube and suspension arm could lead to fall of whole configuration and as a result of that, could lead to serious injury.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights - volista access.Uninitied device movement has been observed due to not constant vertical level of suspension tube.Institution's non-compliance with the project specifications was noticed.There was no injury reported, however, we decided to report the issue in abundance of caution as non-compliance facility could lead to fall of whole configuration and as a result of that, could lead to serious injury.Getinge became aware of an issue with one of surgical lights - volista access.Uninitied device movement has been observed due to not constant vertical level of suspension tube.Institution's non-compliance with the project specifications was noticed.There was no injury reported, however, we decided to report the issue in abundance of caution as non-compliance facility could lead to fall of whole configuration and as a result of that, could lead to serious injury.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 root cause lies in the client's failure to follow the recommendations outlined in the project documentation.The institution has two identical products (same model) installed: one functions perfectly, while the other exhibits an oscillating movement.It remains unclear why the client did not replicate the installation method¿particularly the suspension tube setup¿used for the properly functioning lamp.Consequently, this issue does not stem from a defect in the equipment or an installation error, but rather from the institution's non-compliance with the project specifications.The compliance reports for the device in question were not submitted to the factory.Additionally, the absence of photographic documentation showing the condition of the device before and after the corrective actions is hereby formally noted.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
• 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: 21217559
• Report Number: 9710055-2025-0000027
• Device Sequence Number: 8639706
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: (01)03700712401320
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Followup
• Report Date (Section B): 01/23/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown