MAUDE Adverse Event Report: MAQUET SAS HLED 300&500; LIGHT, SURGICAL, CEILING MOUNTED

Catalog Number ARD568335999

Device Problem Material Fragmentation (1261)

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

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of surgical lights- hled 300&500.As it was stated, paint is peeling from the device.There is no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure might be a source of contamination.(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 investigated by manufacturing site.(b)(4).Exemption # e2018005.(b)(4).

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Maquet sas became aware of an incident with surgical light hled device.As it was stated, the paint was peeled from the device in several places.There is no injury reported however we decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure 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.At the time when the event occurred the device was being used for the 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.The involved zone on the device has visual indications that points to the likeliness of it having been prolongly exposed to cleaning and disinfecting agents.This indicates that cleaning agent residues passed through the painted surfaces and leading to its degradation.The concentration of chemical products, the presence of agent residual on the disinfected surfaces are probably the main factors leading to the deterioration of surfaces.Moreover, the most probable root cause of paintwork damages was also the collision between other products such as spring arm or light head.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.In the product user manual (nu_powerled_01581en doc.Number) manufacturer recommend to perform daily checks of the light head for chipped paint, impact marks and any other damage.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.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.

Event Description

Manufacturer reference number 2019-62973.

• Brand Name: HLED 300&500
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 8508578
• MDR Text Key: 141931851
• Report Number: 9710055-2019-00127
• 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: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ARD568335999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1