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

Model Number ARD567910902

Device Problem Defective Device (2588)

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

Event Date 02/08/2019

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 surgical lights- powerled.As it was stated, the rust occurred on the main arm.There was no injury reported however we decided to report the issue in abundance of caution as any rust particle falling might be a source of contamination.(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 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

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

Event Description

Manufacturer reference number (b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an issue with surgical light powerled device.As it was stated, the rust occurred on the spring arms of the device and resulted in loss of paint integrity.There was no injury reported however we decided to report the issue in abundance of caution as any particle falling into the sterile field might be a source of contamination.It was established that when the event occurred, the device did not meet its specification and it contributed to the event.During the investigation it was found that there is no apparent trend and that the reported scenario has never lead to serious injury or worse.The manufacturer has performed an investigation for that case.The most probable root cause is the collision between other products such as the spring arm or lighthead.The user manuals includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any other similar case, maquet sas recommends to daily check the device for chipped paint, impact marks and any other damage (01581en08, page 38).We believe that if the manufacturer recommendation in the ifu would have been followed the incident would have been avoided.Given the circumstances and the fact that there is no apparent trend in complaints we shall continue to monitor for any further events of this nature and do not propose any further action at this time.If we will receive more information about the issue we will update the investigation.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8390467
• MDR Text Key: 138215183
• Report Number: 9710055-2019-00055
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• PMA/PMN Number: K070442
• 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: 07/24/2019

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: Health Professional
• Device Model Number: ARD567910902
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: 02/08/2019; 02/08/2019; 02/08/2019; 02/08/2019; 02/08/2019; 02/08/2019
• Supplement Dates FDA Received: 03/29/2019; 04/18/2019; 05/14/2019; 06/05/2019; 07/01/2019; 07/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1