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

Device Problem Material Fragmentation (1261)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2019 maquet sas became aware of an issue with one of the surgical light- x-ten.As it was stated, plastic particles were crumbling from device direction handle into the patient area of the operation room.There was no injury reported, however it was decided to report this issue based on the potential as any particles falling off into the sterile field or during operation might be a source of contamination.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

(b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

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

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer's 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's reference number: (b)(4).

Event Description

Manufacturer's reference number: (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of the x ten surgical lights.As it was stated, plastic particles were crumbling from the device¿s direction handle into the patient area of the operation room.There was no injury reported, however it was decided to report this issue based on the potential as any particles falling off into the sterile field or during operation 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 there is no apparent trend in the complaints.Despite several reminders it was not possible to get information about the chemicals used for cleaning.Nevertheless, for such a loss of mechanical characteristics, the hypothesis of a chemical root cause is very likely.The age of these handles combined with not compliant chemical product is the most likely root cause of this phenomenon.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.

• Brand Name: X TEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• MDR Report Key: 8482522
• MDR Text Key: 140933077
• Report Number: 9710055-2019-00108
• 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: Inspection
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2019

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 03/14/2019; 03/14/2019; 03/14/2019; 03/14/2019; 03/14/2019; 03/14/2019; 03/14/2019; 03/14/2019; 03/14/2019; 12/02/2019
• Supplement Dates FDA Received: 04/29/2019; 05/27/2019; 06/21/2019; 07/17/2019; 08/19/2019; 09/03/2019; 09/27/2019; 10/22/2019; 11/18/2019; 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1