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

Model Number	ARDVCS209004A
Medical Device Problem Codes	Corroded (1131); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 12th august 2024 getinge became aware of an issue with one of surgical lights: volista access.It was stated that equipment came into contact with water passing through the central shaft of the equipment, damaging the contacts and the bearing of the upper arm.Also, rust occured in upper arm and the bearing, which was confirmed by photographic evidence.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination, and contact with water may cause electric shock.
Additional Manufacturer Narrative
Event site postal code: (b)(6).Additional information will be provided following the conclusion of the investigation.
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 access.It was stated that equipment came into contact with water passing through the central shaft of the equipment, damaging the contacts and the bearing of the upper arm.Also, rust occured in upper arm and the bearing, which was confirmed by photographic evidence.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination, and contact with water 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 device was or was 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 or excessive cleaning product used from the facility, 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.

• Brand Name: VOLISTA ACCESS
• 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: 20035185
• Report Number: 9710055-2024-00482
• Device Sequence Number: 14211839
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: (01)03700712401320
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130513
• 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): 08/22/2024

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: ARDVCS209004A
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown