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  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 50.It was stated the cover was cracked and the particles was missing.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

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

Manufacturer Narrative

Getinge became aware of an issue with two surgical lights lucea 50.It was stated that covers were cracked and the particles were missing.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.Based on the information collected, it was established that when the event occurred, surgical lights did not meet their specification, since cracks in covers, resulting in missing plastic particles could be considered as technical deficiency, and in this way devices contributed to event.It is unknown if claimed devices were or were not being used for patient treatment or diagnosis when the event took place.When reviewing reportable events for this type of issues we were able to establish that the received incident is occurring at a low 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 a broken parts are missing.The damages were probably caused by a collision.A new covers available as spare parts in the kit must be installed in order to replace damaged covers and to avoid any incident.To prevent any safety issue the lucea 50/100 instruction for use (01741 rev.10, pages 26-27) mentions to check the light heads for chipped paint, impact marks and any other damage, during the daily check.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.

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: 13993461
• MDR Text Key: 288483497
• Report Number: 9710055-2022-00104
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• 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?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1