MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LAMP, SURGICAL

Model Number ARD568604998

Device Problem 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 21st june 2022, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was cracked with missing 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 cause contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, cover was cracked with particles detected missing.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.Defective parts were replaced and device back to usage.Based on the information collected, it was established that when the event occurred, the surgical lights assembly did not meet their specification, since cracked cover leading to missing particles could be considered as technical deficiency, and in this way the device contributed to the event.Provided information does not indicate if upon the event occurrence, the device was or was not being used for patient treatment.When reviewing reportable events for this type of issues we were able to establish that the received incidents are occurring at moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.According to pictures provided, plastic top covers are deteriorated in corners and broken parts are missing.Based on what was reported by the technician who visited the customer and inspected the device on-site, it comes forward that the issue is a result of damage being directly caused by the user.To prevent any safety issue user manual for lucea 50/100 (ifu 01741 en 10, pages 26-27) mentions to check the light heads for chipped paint, impact marks and any other damage, during the daily check.New covers are available as spare parts in a replacement kit and must be installed in order to replace damaged covers and to avoid any incident.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would have been avoided.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date 2021-04-09; corrected h4 manufacture date 2021-04-12.According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA 50
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 14998195
• MDR Text Key: 304465215
• Report Number: 9710055-2022-00265
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568604998
• Device Catalogue Number: ARD568604998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 08/02/2022; 09/12/2022
• Supplement Dates FDA Received: 08/24/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1