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

Model Number ARDVCS209006A

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On 13th of july 2020 getinge became aware of an issue with one of our surgical light ¿ volista access.As it was stated during the procedure both available cupolas turned off.Despite this inconvenience the procedure was ended without any delays and no injury was reported however we decided to report this issue in abundance of caution as in case when both light unexpected turned off it could led to injury.Manufacturer's reference number (b)(4).

Event Description

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

Manufacturer Narrative

The issue is being investigated by the manufacturing site.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical light ¿ volista access.As it was stated during the procedure both available cupolas turned off and there was no additional light available.Despite this inconvenience the procedure was ended without any delays and no injury was reported however we decided to report this issue in abundance of caution as in case when both light unexpected turned off it could led to injury.It was established that when the event occurred, the surgical light did not meet its specification as turning off of both cupolas is considered as technical deficiency.The device contributed to the event.The provided information indicate that upon the event occurrence the device was being used for patient treatment.It has been established that the most likely root cause of the issue is connected with issue at facility site.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

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

• Brand Name: VOLISTA ACCESS
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 10275369
• MDR Text Key: 198880805
• Report Number: 9710055-2020-00218
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

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 Operator: Health Professional
• Device Model Number: ARDVCS209006A
• Device Catalogue Number: ARDVCS209006A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 07/22/2020; 02/16/2021
• Supplement Dates FDA Received: 08/14/2020; 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1