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

Model Number ARD567910990

Device Problems Material Discolored (1170); Material Erosion (1214)

Patient Problem No Information (3190)

Event Date 05/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is being investigated by manufacturing site.

Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- volista.As it was stated by the technician, the main arm started to rust.There was no injury or contamination reported however we decided to report the issue in abundance of caution.(b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).The issue will be investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).Maquet (b)(4) became aware of an incident with surgical light volista device.As it was stated by the technician, the main arm started to rust.There was no injury or contamination by falling rust particles reported however we decided to report the issue in abundance of caution.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the issue.The information about the time when the event occurred was not provided, we do not know if the device was not being used for the patient treatment.During the investigation it was found that to date the issue appears not to be a systematic problem, rather a single issue - and that the reported scenario has never lead, to date, to serious injury or worse.The device has been recognized as volista standop with serial numbers (b)(4) and defective part number ard567910990.Installation date of the device is (b)(6) 2016.The manufacturing date is 15th february, 2016.As a fumigation was used by the customer to clean and disinfect the device, the method has led to paint peeling, corrosion and plastic degradation.The correct cleaning protocol was reminded to the customer as fumigation of the device is prohibited.The user manual (standop volista user manual 01761en ed.07 page 63) also included an information that the fumigation method mustn¿t be used to clean and disinfect the device.What is more, every user is informed in user manual (standop volista user manual 01761en ed.07 page 65) to daily check the light-head for chipped paint, impact marks and any other damage.In summary, based on the investigation performed, we have concluded the root cause to be related with user error, who was not following the recommended instruction of device cleaning procedure.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.

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7548801
• MDR Text Key: 109628087
• Report Number: 9710055-2018-00037
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K130513
• 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: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD567910990
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1