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

Model Number ARD568805901

Device Problem Leak/Splash (1354)

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

Event Date 06/20/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 : device not returned to manufacturer.

Event Description

On 20th june, 2023 getinge became aware of an issue with one of surgical lights ¿ volista access.As it was stated the water was accumulated inside the lamp.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock.

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 06/07/2022.Corrected h4 manufacture date: 06/08/2022.According to the information gathered, the head lamp was dismounted and cleaned, and light is now fully operational.It was established that when the event occurred, the surgical light did not meet their specifications since presence of water affects surgical light¿s functionality and safeness, and in this way, device contributed to event.Gathered information suggests that the device was not being used for patient treatment at the time when the event occurred.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 claimed devices to the number of sold devices worldwide, we can assume that 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, the volista surgical light is not supplied with water and is not a source of a leak.The involved lights must be opened and cleaned.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: 17169752
• MDR Text Key: 317659701
• Report Number: 9710055-2023-00454
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 06/21/2023

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?: No
• Device Model Number: ARD568805901
• Device Catalogue Number: ARD568805901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 10/02/2023
• Supplement Dates FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1