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

Model Number ARD568604998

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/23/2023

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) 2023, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, the mounting screw was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ lucea 50 (mobile version).As it was stated, the base screw supporting the mastil was missing, causing the lamp base was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.The lamp was installed in a veterinary clinic, the patients were animals.In the worst case scenario, if this issue occurred elsewhere, it could cause risk to human life.According to the information provided by getinge technician the issue was solved by replacing the screw and the lamp is working fine.Based on the information collected, it was established that when the event occurred, the surgical light did not meet its specification, since the mounting screw was missing which could be considered as technical deficiency, and in this way the device contributed to the event.Provided information indicate that upon the event occurrence the device was not being used for patient treatment nor diagnosis.When reviewing reportable events for this type of issue we were able to establish that the received incidents are occurring at a very low ratio.We have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Unfortunately, maquet sas did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause nor provide the most probable root causes.In case of new relevant information, the case will be reconsidered.According to the information provided by getinge technician, the affected device is not under service agreement.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 23rd january 2023, getinge became aware of an issue with one of our surgical lights ¿ lucea 50.As it was stated, the mounting screw was missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.Corrected b5 describe event and problem: on 23rd january 2023, getinge became aware of an issue with one of our surgical lights ¿ lucea 50 (mobile version).As it was stated, the base screw supporting the mastil was missing, causing the lamp base was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

Event Description

On 23rd january 2023, getinge became aware of an issue with one of our surgical lights ¿ lucea 50 (mobile version).As it was stated, the base screw supporting the mastil was missing, causing the lamp base was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may cause contamination or serious injury.

• 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: 16319401
• MDR Text Key: 309017754
• Report Number: 9710055-2023-00098
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/03/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1