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

Model Number	ARDVST229033A
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 one of surgical lights - volista standop.It was stated that the spring arm cover has been scratched and causes scrapings fall into the surgical field.Designated complaint unit employee confirmed reported issue based on photographic evidence.No injuries were reported for the patient and no medical intervention was required as a result of the incident.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.
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of surgical lights - volista standop.It was stated that the spring arm cover has been scratched and causes scrapings fall into the surgical field.Designated complaint unit employee confirmed reported issue based on photographic evidence.No injuries were reported for the patient and no medical intervention was required as a result of the incident.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.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 indicate that upon the event occurrence, the device was being used for patient treatment.According to analysis provided by subject matter expert at manufacturer¿s, the minor and deep scratches are caused by impacts or collisions resulting from abnormal use.The operating manual provides instructions to pre-position the arms before use to prevent damage.To avoid similar incidents, it is recommended to prevent collisions between devices.Visual inspections during cleaning help detect scratches; any parts showing severe damage must be replaced.Getinge shall continue to monitor for any further events of this nature and does not propose any further action at this time.

• 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: 23356030
• Report Number: 9710055-2025-0000277
• Device Sequence Number: 8871998
• Product Code: FSY
• UDI-Device Identifier: 03700712401474
• UDI-Public: (01)03700712401474
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/22/2025

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: ARDVST229033A
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown