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

Model Number ARDLCA109001A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/23/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 40.It was stated the cover of the headlight cracked and the particles were missing.There was no injury reported, however, we decided to report the issue in abundance of caution as any detachment of part or particles may lead to potential infection of the patient.

Manufacturer Narrative

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

Event Description

Manufacturer's reference number (b)(4).

Manufacturer Narrative

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.The correction of catalog# field deem required.This is based on the internal evaluation.#d4: previous catalog #: ardlca109001a.Corrected catalog#: ard568601997.

Manufacturer Narrative

Getinge became aware of an issue with the examination light lucea 40.It was stated the cover of the headlight cracked and the particles were missing.There was no injury reported, however, we decided to report the issue in an abundance of caution as any detachment of part or particles may lead to potential infection of the patient.Based on the information collected, it was established that when the event occurred, the examination 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 the device contributed to the event.The provided information indicates that upon the event occurrence the device was being used for patient diagnosis.When reviewing reportable events for this type of issue we were able to establish that the received incidents are 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 per expertise performed by the subject matter expert at the 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 11) on page 21 mentions to check the integrity of the light heads during daily inspection.Furthermore, the same user manual on pages 28-29 explains how to clean and disinfect the lightheads.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 11) on page 24 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.The correction of e1a initial reporter, e1c event site address, e1e event site city, e1h event site postal code fields deems required.This is based on the internal evaluation.Previous e1a initial reporter: (b)(6).Corrected e1a initial reporter: n/a.Previous e1c event site address: (b)(6).Corrected e1c event site address: (b)(6).Previous e1e event site city: (b)(6).Corrected e1e event site city: (b)(6).Previous e1h event site postal code: (b)(6).Corrected e1h event site postal code: (b)(6).

Event Description

Manufacturer's reference number ot (b)(4).

• Brand Name: LUCEA 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: 15081719
• MDR Text Key: 302025751
• Report Number: 9710055-2022-00299
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARDLCA109001A
• Device Catalogue Number: ARD568601997
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1