MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LAMP, SURGICAL

Catalog Number ARDLCA309007A

Device Problem Crack (1135)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of devices- lucea 100.As it was stated, the cover of the light head is cracked and it resulted in missing plastic particles.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may be a source of contamination.

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.

Event Description

Manufacturer 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 reference number: (b)(4).

Manufacturer Narrative

The issue is still being investigated by manufacturing site.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of devices- lucea 100.As it was stated, the cover of the light head is cracked and it resulted in missing plastic particles.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may 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 issue.The device was not being used for patient treatment.Based on the performed trend review we conclude that there is no apparent trend for the issue with this device and that this is the second complaint of this nature received in last 5 years.In user manual 01741en05, there is an information included to check the device for impact marks and any other damage.It was established that most likely root cause is related to wrong maintenance of the device, however due to limited information received from ssu, subject matter experts were unable fully confirm this root cause.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer reference number: 215789.

Manufacturer Narrative

The purpose of this submission is solely to provide a correction of additional manufacturer narrative/corrected data section.This is based on the result of an internal review.#h10: previous additional manufacturer narrative/corrected data: getinge became aware of an issue with one of devices- lucea 100.As it was stated, the cover of the light head is cracked and it resulted in missing plastic particles.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may 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 issue.The device was not being used for patient treatment.Based on the performed trend review we conclude that there is no apparent trend for the issue with this device and that this is the second complaint of this nature received in last 5 years.In user manual 01741en05, there is an information included to check the device for impact marks and any other damage.It was established that most likely root cause is related to wrong maintenance of the device, however due to limited information received from ssu, subject matter experts were unable fully confirm this root cause.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.Corrected additional manufacturer narrative/corrected data: getinge became aware of an issue with one of devices- lucea 100.As it was stated, the cover of the light head is cracked and it resulted in missing plastic particles.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may 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 issue.The device was not being used for patient treatment.Based on the performed trend review we conclude that there is no apparent trend for the issue with this device and that this is the 24th complaint of this nature received in last 5 years.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: mechanical stress, environmental conditions (such a high temperature and humidity variations during transport and storage), use of inappropriate cleaning/disinfections products, or inappropriate cleaning and disinfection protocols.We believe that all remaining devices are performing correctly in the market.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.Given the circumstances 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: (b)(4).

• Brand Name: LUCEA 100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 8734474
• MDR Text Key: 149193521
• Report Number: 9710055-2019-00206
• Device Sequence Number: 1
• Product Code: FTD
• 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: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARDLCA309007A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1