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

Model Number	ARDVCS209030A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 16th february, 2024 getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the water was leaking from the ceiling, after breakage of water system pipe and the damage certainly spread within the electrical circuitry and on the rotating contacts inside the suspension arms.It was confirmed by photographic evidence the the water has infiltrated inside the dome.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.
Additional Manufacturer Narrative
Event site name: (b)(6).Event site telephone: (b)(6).Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Additional Manufacturer Narrative
The correction of h4 manufacture date, h3a device evaluated by mfg, h3b device not eval provide code and h3c if other provide code-explain deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2023-09-04, corrected h4 manufacture date: 2023-09-06.Previous h3a device evaluated by mfg: no, corrected h3a device evaluated by mfg: yes.Previous h3b device not eval provide code: other, corrected h3b device not eval provide code: none.Previous h3c if other provide code-explain: device not returned to manufacturer, corrected h3c if other provide code-explain: none.Getinge became aware of an issue with one of surgical lights - volista access ii.It was stated the water was leaking from the ceiling, after breakage of water system pipe and the damage certainly spread within the electrical circuitry and on the rotating contacts inside the suspension arms.It was confirmed by photographic evidence the water has infiltrated inside the dome.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.Based on the information collected, it was established that when the event occurred, the surgical light 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.Subject matter expert established that according to the information provided the presence of water in the device is the result of a water leakage, it is a phenomenon external to the device.This problem is not related to the device, the or surgical light is not supplied with water and is not a source of a leak.For safety reasons a functional check of the device is required to verify the absence of damage.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 (b)(4).

• Brand Name: VOLISTA ACCESS II
• 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: 18798127
• Report Number: 9710055-2024-00182
• Device Sequence Number: 7294434
• Product Code: FSY
• UDI-Device Identifier: 03700712420635
• UDI-Public: (01)03700712420635
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/28/2024

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: ARDVCS209030A
• Device Catalogue Number: ARDVCS209030A
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown