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

Model Number	ARDVST229039A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was peeling from the fork.The issue was confirmed by photographic evidence.We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
The unique identifier (udi) # information is not available as this medical device/model was marketed and/or discontinued in us before the udi requirement became mandatory.Event site name: cent.Hospitalier de saintonge additional information will be provided following the conclusion of the investigation.
Event or Problem Description
Manufacturer's reference number (b)(6).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista standop.It was stated the paint was peeling from the fork.The issue was confirmed by photographic evidence.We decided to report the issue in abundance of caution as any paint 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.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.According to analysis provided by subject matter expert at manufacturer¿s, the paint chipping was caused by a lack of paint adhesion due to the painting process.Indeed, the surface was too smooth after nitrocarburizing and the paint did not remain adherent overtime for some of the pieces or batches.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).
Additional Manufacturer Narrative
The correction of d1 brand name, d4 catalog #, unique identifier (udi) #, field deems required.This is based on the internal evaluation.Previous d1 brand name: volista standop.Corrected d1 brand name: standop volista®.Previous d4 unique identifier (udi) #: blank.Corrected d4 unique identifier (udi) #: (b)(4).Previous d4 catalog#: ardvst229039a.Corrected d4 catalog#: blank.
Additional Manufacturer Narrative
The correction of d4 catalog #, version or model # and serial # field deems required.This is based on the internal evaluation.Previous d4 version or model #: ard568821960 corrected d4 version or model #: ardvst229039a previous d4 catalog#: ard568821960 corrected d4 catalog#: ardvst229039a previous d4 serial#: (b)(6).Corrected d4 serial#: (b)(6).
Event or Problem Description
Manufacturer's reference number ot#(b)(4).

• Brand Name: STANDOP 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: sylviane boiron bourgeois ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 23025076
• Report Number: 9710055-2025-0000228
• Device Sequence Number: 18505290
• Product Code: FSY
• UDI-Device Identifier: 03700712401634
• UDI-Public: (01)03700712401634
• 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,Followup,Followup
• Report Date (Section B): 09/11/2025

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: ARDVST229039A
• Device Catalogue Number: ARDVST229039A
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 04/09/2026; 04/10/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 11/25/2025; 04/10/2026; 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown