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

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of surgical lights- volista 600.As it was stated, the crack on the bracket was found.There was no injury reported however we decided to report the issue in abundance of caution as the crack may lead to the detachment of the light head and it may lead to a serious injury or worse.(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.

Event Description

Manufacturer reference number (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.

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.Getinge usa sales, llc (importer) is submitting this report on behalf of the legal manufacturer of the device maquet sas, parc de limère, avenue de la pomme de pi orléans cedex 2, france 45074.Exemption # e2018005.Getinge usa sales, llc, 45 barbour pond drive, wayne, nj 07470.Contact person: (b)(6).

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number 2019-63180.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Manufacturer Narrative

Maquet sas became aware of an incident with surgical lights volista¿s device.As it was stated, the bracket cracked.There was no injury reported as the failure was found during maintenance activities, nevertheless we decided to report the issue in abundance of caution as cracked bracket could lead to the detachment of cupola and cause an injury.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.At the time when the event occurred the device was not being used for patient treatment.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.The mechanical interface is not designed to resist the torque applied at this location with only two screws.To sum up, the issue occurrence is due to manufacturing - human error.The affected devices are now being updated during field safety corrective action msa-2018-001-iu (z-2502-2018).The device involved in the event was found to be in the scope of mentioned fsca, however the activities related with an action were not yet done on the unit.After the event occurrence, the defective cupola was replaced and the device was returned to use.

Event Description

Manufacturer's reference number 2019-63180.

• 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: 8503306
• MDR Text Key: 141746762
• Report Number: 9710055-2019-00122
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1