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

Model Number	ARDVST229029A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
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 and confirmed by photographic evidence the spring arm cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista standop.It was stated and confirmed by photographic evidence the spring arm cover was cracked with missing particles.We decided to report the issue in abundance of caution as any 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: in the photo, we can notice the absence of the cap, its screw, and the missing parts of the side cover.We have no information regarding the circumstances of this incident.The breakage of side cover is due to: impacts, collisions (abnormal use).To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect appearance defect, we recommend to perform corrective maintenance to rectify the default after its detection.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
Additional information will be provided following the conclusion of the investigation.Event site name: (b)(6) hospital event site postal code: (b)(6).

• Brand Name: VOLISTA STANDOP
• 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: 21705279
• Report Number: 9710055-2025-0000109
• Device Sequence Number: 9941877
• Product Code: FSY
• UDI-Device Identifier: 03700712401658
• UDI-Public: 03700712401658
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/26/2025

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: ARDVST229029A
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown