MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LIGHT, SURGICAL, FLOOR STANDING

Model Number ARDLCA309004A

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On 4th august, 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 50.According to photographic evidence, the 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.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Manufacturer Narrative

The correction of h4 manufacture date deems required.This is based on the internal evaluation.Previous h4 manufacture date: 2019-10-03.Corrected h4 manufacture date: 2019-10-21.Getinge became aware of an issue with one of our surgical lights ¿ lucea 50.According to photographic evidence, the 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.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.The issue has been analyzed by the subject matter expert and concluded that according to the picture provided, plastic top covers are deteriorated in the corner and a broken part is missing.The damages were probably caused by a collision.The cover involved was not returned for evaluation.A new cover available as spare parts in the kit must be installed in order to replace the cover damaged and to avoid any incident.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.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendation had been followed the incident could 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: LIGHT, SURGICAL, FLOOR STANDING
• 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: 15257224
• MDR Text Key: 305246950
• Report Number: 9710055-2022-00342
• Device Sequence Number: 1
• Product Code: FSS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA309004A
• Device Catalogue Number: ARD568604998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/21/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1