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

Model Number ARD368609996

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/31/2022

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), 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.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

The correction of d4 catalog # and version or model # deems required.This is based on the internal evaluation.Previous d4 catalog #: ardlca109004a; corrected d4 catalog #: ard368609996; previous d4 version or model #: ardlca109004a; corrected d4 version or model #: ard368609996.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.

Manufacturer Narrative

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.According to the information provided by getinge technician, the device was repaired and returned to use.Based on the information collected, it was established that when the event occurred, surgical light did not meet its specification, since cracks in covers, resulting in missing plastic particles could be considered as technical deficiency, and in this way device contributed to event.It is unknown if claimed device was or was 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 moderate ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.As stated by subject matter expert, 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's 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: 13993532
• MDR Text Key: 288481976
• Report Number: 9710055-2022-00105
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,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: ARD368609996
• Device Catalogue Number: ARD368609996
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1