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

Catalog Number ARD568811951

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue is 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, the bumper fell off during surgery.There was no injury reported.

Event Description

Manufacturer reference number 2018-59059.

Manufacturer Narrative

(b)(4).Exemption # e2018005.(b)(4).Maquet (b)(4) became aware of an incident with a surgical light volista standop device.As it was stated, the bumper fell off during surgery.There was no injury reported.There are no known clinical consequences for the patient.Bumper is used to cover the bottom of the main tube and access to cables inside the surgical light.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.In the time when event occurred the device was used for patient treatment.During the investigation it was found that the reported scenario has never lead to serious injury or worse, to death.As per performed tests the root cause of falling bumper is likely caused by several violent collisions with the cupolas, this happens while the user is not being careful with moving the device arms and lights.The product volista standop user manual 01761en ed.08 on page 12 includes an information that the safety and integrity of the operation of the product are guaranteed only if all inspection, maintenance and repair operations are performed by a maquet engineer or an authorized technician.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 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.

• Brand Name: VOLISTA STANDOP
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7471974
• MDR Text Key: 107195571
• Report Number: 9710055-2018-00023
• 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
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568811951
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1