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

Model Number ARDLCA219001A

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

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2021 getinge became aware of an issue with surgical light ¿ lucea 100.The cover was cracked, leading to missing plastic particles.The issue was confirmed by the photographic evidence.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling may lead to contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with surgical light ¿ lucea 100.The cover was cracked, leading to missing plastic particles.The issue was confirmed by the photographic evidence.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling may lead to contamination.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: cracks located on the light head lower covers, at the edge of the on/off button, were detected during daily visual inspection, as recommended by the user manual.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.For cleaning, the ifu informs the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and to use inappropriate disinfectants.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.Based on the investigations the most probable root cause of the cracks is a combination of different factors: mechanical stress, use of inappropriate cleaning/disinfection products, or inappropriate cleaning and disinfection protocols.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.

• 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: 12225023
• MDR Text Key: 263396740
• Report Number: 9710055-2021-00251
• 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
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA219001A
• Device Catalogue Number: ARDLCA219001A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1