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

Model Number ARDVCS209004A

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On (b)(6)2022 getinge became aware of an issue with one of surgical lights ¿ volista access.As it was stated the water was accumulated in the dome.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.

Manufacturer Narrative

The initial reporter was the clinical engineer at the hospital.Getinge became aware of an issue with one of surgical lights ¿ volista access.As it was stated the water was accumulated in the dome.According to the information gathered, there was a leak comming from the upper floor.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.There was also an allegation about smoke smell coming from the room where the device was assembled, however as it was further clarified the smell had been coming from the air conditioning external to getinge equipment.The getinge service technician was requested to evaluate the integrity of the surgical light which suffered from the described issue.Based on his statement, the phenomenon with the water leakage was already remedied by the customer.During the inspection he opened the dome and checked internal components such as arm connectors as well as all the critical points guaranteeing the integrity of the device.The affected surgical light was tested and released for use without any abnormality.It was established that when the event occurred, the surgical light did not meet its specification, since presence of water affects surgical light¿s functionality and safeness, and in this way, device contributed to event.The provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Comparing the number of complained devices to the install base of the volista range, we can conclude the failure ratio is very low.A root cause analysis was performed by subject matter expert at manufacturing site.As they stated, according to the information provided the presence of water in the power supply of the surgical light is the result of a water leakage from the ceiling of the facility.It is a phenomenon external to the device.This problem is not related to the device since the volista surgical light itself is not supplied with water and is not a source of a leak.We believe the related devices are performing correctly in the market, as the issue occurred due to the customer¿s facility issue.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: VOLISTA ACCESS
• Type of Device: 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: 16596332
• MDR Text Key: 311829833
• Report Number: 9710055-2023-00242
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 03700712401320
• UDI-Public: (01)03700712401320
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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
• Device Catalogue Number: ARDVCS209004A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/26/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1