MAUDE Adverse Event Report: MAQUET SAS VOLISTA STANDOP; LAMP, SURGICAL

Model Number ARDSTP229008

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by the manufacturing site.Device not returned to manufacturer.

Event Description

On (b)(6) 2019 getinge became aware of an issue with surgical light ¿ volista standop df 64.As it was stated, the rust was found on fork and spring arm.There was no injury reported however we decided to report the issue in abundance of caution as corrosion may lead to particles falling and then might cause contamination.

Manufacturer Narrative

The issue is still being investigated by the manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by the manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with surgical light ¿ volista standop df 64.As it was stated, the rust was found on fork and spring arm.There was no injury reported however we decided to report the issue in abundance of caution as corrosion may lead to particles falling and then might cause contamination.When reviewing similar reportable events registered for volista surgical light we were able to find several similar issues compared to the problem investigated herein.In none of the complaints a serious injury or death occurred.Based on the information collected to date it was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.We conclude that the most likely root cause is related to wrong maintenance of the device.It is worth to be noted that volista user manual indicates that the light should be daily checked for any impact marks and how to clean the device.We believe that remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature 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 reference number 272704.

• Brand Name: VOLISTA STANDOP
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 9443328
• MDR Text Key: 178211127
• Report Number: 9710055-2019-00357
• Device Sequence Number: 1
• Product Code: FTD
• 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,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDSTP229008
• Device Catalogue Number: ARDSTP229008
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1