MAUDE Adverse Event Report: MAQUET SAS X-TEN; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD567800999

Device Problem Peeled/Delaminated (1454)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

The issue is being investigated by manufacturing site.(b)(4).Device not returned to manufacturer.

Event Description

On (b)(6) 2019 maquet (b)(4) became aware of an issue with one of surgical lights- x-ten.As it was stated by customer, light head had paint chips which fell into patient in the field.There was no adverse consequences reported however we decided to report the issue based on the potential as any paint particles falling off into sterile field may be a source of contamination.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturing 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

Manufacturing 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

Manufacturing reference number (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: (b)(4).

Event Description

Manufacturing reference number (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Getinge became aware of an incident with one of surgical lights- x-ten.As it was stated, the paint was chipping.There was no patient involvement however we decided to report the issue in abundance of caution as any paint particle falling might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its 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.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death.A root cause investigation by the subject matter experts at the manufacturing site points out that the peeled paint is most likely caused by a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning or disinfection protocol.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendations 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.

Event Description

Manufacturer reference number: 215319.

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number: 215319.

• Brand Name: X-TEN
• 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: 8659007
• MDR Text Key: 146676291
• Report Number: 9710055-2019-00188
• 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: Notification
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD567800999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 05/31/2019
• Supplement Dates Manufacturer Received: 05/30/2019; 05/30/2019; 05/30/2019; 05/30/2019; 05/30/2019; 05/30/2019; 05/30/2019; 12/21/2019; 02/03/2020
• Supplement Dates FDA Received: 06/25/2019; 07/17/2019; 08/09/2019; 09/03/2019; 09/27/2019; 10/23/2019; 11/20/2019; 01/15/2020; 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1