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

Catalog Number ARD568330931

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- powerled.As it was stated, the underside cover of the light head was cracked.There is no injury reported however we decided to report the issue in abundance of caution as any particle falling into the sterile filed might cause a 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 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

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.Maquet sas became aware of an issue with powerled device.As it was stated, the underside cover of the light head was cracked and it resulted in some particles of it having become missing.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 cause a contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.It was not established if in the time when the event occurred the device was or was not being used for the patient treatment.During the investigation, it was found that the issue is single, isolated event and that the reported scenario has never led, to date, to serious injury or worse.The issue was consulted with subject matter experts and the most likely root cause for this issue is wrong cleaning and disinfecting agents used on the light head¿s surface.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

• Brand Name: POWERLED
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; orléans cedex 2 ; FR
• MDR Report Key: 8133178
• MDR Text Key: 129456648
• Report Number: 9710055-2018-00195
• 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
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568330931
• Was Device Available for Evaluation?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other