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

Model Number	ARDVCS209027A
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6) event site postal code: (b)(6) event site telephone: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that the ring of celling cover has been damaged.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 or injury.
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that the ring of celling cover has been damaged.The incident was initially assessed as reportable, as any parts falling off into sterile field or during procedure may cause contamination or injury.Recently, the incident has been reevaluated as new information become available, it was determined that the issue occurred during installation of the device prior it was released for use.Therefore, the scenario described in the record is considered as non-reportable.
Additional Manufacturer Narrative
The correction of b5 describe event and problem, h6 medical device ¿ problem code 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 ii.It was stated that the ring of celling cover has been damaged.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 or injury.Corrected b5 describe event and problem: getinge became aware of an issue with one of surgical lights - volista access ii.It was stated that the ring of celling cover has been damaged.The incident was initially assessed as reportable, as any parts falling off into sterile field or during procedure may cause contamination or injury.Recently, the incident has been reevaluated as new information become available, it was determined that the issue occurred during installation of the device prior it was released for use.Therefore, the scenario described in the record is considered as non-reportable.Previous h6 medical device ¿ problem code: material integrity problem|||2978.Corrected h6 medical device ¿ problem code: mechanical problem|||1384.Initially provided information was pointing to damaged celling ring cover.The issue is considered as safety related as any parts falling off into sterile field or during procedure may cause contamination or injury.Recently, the incident has been reevaluated as new information become available, it was established that the issue occurred during installation of the device prior it was released for clinical use.According to new information gathered, initial information was incorrect.It was determined that the issue investigated herein is not safety and risk related as it was detected during installation of the device prior it was released for clinical use.The investigation was performed.The review of the customer product complaints, related to investigated issue in time, shows that there is no regular income.No apparent reason was identified for suggesting to open a capa or evaluation for the need of another action in the market.

• 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: 23664351
• Report Number: 9710055-2025-0000302
• Device Sequence Number: 10402063
• Product Code: FSY
• UDI-Device Identifier: 03700712420604
• UDI-Public: (01)03700712420604
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/27/2025

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: ARDVCS209027A
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown