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

Catalog Number ARD568811960

Device Problems Crack (1135); Component Missing (2306)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of the surgical lights- volista.It was stated that the bracket on the cupola was broken and the bottom screw was missing from the device.There was no injury reported, however it was decided to report this issue based on the potential as the crack on the device bracket might lead to detachment of the cupola and consequently to an adverse event.(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Maquet sas became aware of an issue with surgical light volista device related to broken bracket.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.During the investigation it was found that the occurrence rate for the issue of the light head shaft breaking is low (total of (b)(4) complaints in the last 5 years of daily use of a large number of similar devices).The investigation was performed by product specialists at the manufacturer.It was established that the root cause of this incident is that one of three screws was missing.The lack of marks on metal at the screw location is concrete evidence of that fact.This screw has been forgotten on the assembly line during manufacturing process.The control process has been reinforced since (b)(6) , 2016 and the check of the presence of these 3 screws is now required.To sum up, the issue occurrence is due to manufacturing-man error.The affected devices are now being updated during field safety corrective action msa-2018-001-iu.The device involved in the event was found to be in the scope of mentioned fsca yet not addressed before the issue occurrence.Getinge does not propose any other action at this time.

Event Description

Manufacturer reference number: 2019-62993.

• Brand Name: VOLISTA
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 8461268
• MDR Text Key: 140314839
• Report Number: 9710055-2019-00104
• 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,Followup,Followup
• Report Date: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD568811960
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1