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

Catalog Number ARD568350933

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The issue will be investigated by manufacturing site.

Event Description

On (b)(6) 2017 maquet (b)(4) became aware of an incident with one of surgical lights- powerled.As it was stated, the paint is chipping.The circumstances of the issue are unkown however we decided to report this case in abundance of caution.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

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

Event Description

Manufacturer reference number: (b)(4).

Manufacturer Narrative

Maquet (b)(4).Became aware of an incident with a surgical light powerled device.As it was stated, the paint was found to be chipping.Unfortunately, despite several attempts in gathering additional information we could not establish the circumstances under which the problem was discovered.Therefore, we decided to report it to competent authorities in abundance of caution and based on the potential , as any particle falling off the device during surgery 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 event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.As we did not receive the information about preventive maintenance of the device nor about the installation of it, the assumed root cause in the manufacturer¿s investigation is likely caused by a shock during a collision.The product powerled user manual 01581en ed.07 page 38 includes an information to daily check the device for chipped paint.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation 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.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number: (b)(4).

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 7185990
• MDR Text Key: 97766076
• Report Number: 9710055-2018-00001
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/14/2018

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 Catalogue Number: ARD568350933
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 12/14/2017; 12/14/2017; 12/14/2017
• Supplement Dates FDA Received: 03/21/2018; 05/23/2018; 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1