MAUDE Adverse Event Report: MAQUET SAS LUCEA 10/40; DEVICE, MEDICAL EXAMINATION, AC POWERED

Model Number ARD568601997

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 getinge became aware of an issue with one of examination lights - lucea 10/40.Based on photographic evidence the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause serious injury.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3: device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an issue with one of examination lights - lucea 10/40.Based on photographic evidence the cover was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause serious injury.Defective part handle interface with fork (ard368605998) was replaced and device is ready to use.Based on the information collected, it was established that when the event occurred, surgical light did not meet their specification, since cover was cracked with missing particles could be considered as a technical deficiency, and in this way the device contributed to the event.The provided information does indicate if upon the event occurrence, the device was not being used for patient treatment.The review of received customer product complaints related to the investigated issue revealed that there were no injuries to a user nor to a patient or operator when this malfunction occurred.Comparing the number of claimed devices to the number of sold devices worldwide, we can assume that the failure ratio of the covers were damaged with missing particles is moderate.As per expertise performed by the subject matter expert at manufacturing site the cracks detected on the handle interface and transparent cover fixing points were probably caused by improper use, collisions, incompatible cleaning products or protocol.To prevent any incident the user manual for lucea 10/40 (ifu 01701 en 12) on page 22 mentions to check the integrity of the light heads during daily inspection.Furthermore, the same user manual on pages 29-30 explains how to clean and disinfect the light heads.This document includes some recommended products and some prohibited products.In order to avoid torques applied on the transparent housing during use the user manual for lucea 10/40 (ifu 01701 en 12) on page 25 mentions to handle the light head by the handle.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 10/40
• Type of Device: DEVICE, MEDICAL EXAMINATION, AC POWERED
• 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: 17196878
• MDR Text Key: 317818867
• Report Number: 9710055-2023-00468
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568601997
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1