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

Model Number ARD568603999

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 17th may, 2021 getinge became aware of an issue with lucea 100 surgical light.The cover was cracked and particles were missing, what was confirmed by a photographic evidence.There was no injury reported, however, we decided to report the issue in abundance of caution as any particles falling off into steriel field or during procedure may cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.The correction of h4 manufacture date field deems required.This is based on the internal evaluation.Previous h4 manufacture date: 5th july 2017.Corrected h4 manufacture date: 5th september 2017.

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with lucea 100 surgical light.The cover was cracked and particles were missing, what was confirmed by a photographic evidence.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 cause contamination.The light was fixed by getinge technician and was returned to service.During the investigation, it was concluded that the device involved did not meet the manufacturer¿s specification and it contributed to the event.We have not received information whether the device was being used for patient treatment at the time when the event occurred.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse.The subject matter experts at the manufacturing site have investigated this type of issue and concluded as follows: the incident is due to a mechanical stress or an inappropriate use.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.To prevent any incident the lucea50-100 user manual mentions : ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections.We believe that all remaining devices are performing correctly in the market.Given the circumstances and after our review of complaint ratio behavior 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's reference number (b)(4).

• Brand Name: LUCEA
• 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: 11848593
• MDR Text Key: 251425473
• Report Number: 9710055-2021-00196
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARD568603999
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2021
• Patient Sequence Number: 1