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

Catalog Number ARD568601998

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of our surgical lights ¿ lucea 40.As it was stated 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 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.

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.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of our surgical lights ¿ lucea 40.As it was stated 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 lead to potential infection of the patient.According to the information provided by getinge technician, the affected device was repaired by transparent plastic cover (ard 368606555) replacement.Based on the information collected, it was established that when the event occurred, surgical lights did not meet their specification, since cracks in covers, resulting in missing plastic particles or detachment of the cover could be considered as a technical deficiency, and in this way the device contributed to the event.The 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 issue we were able to establish that the received incidents are occurring at moderate ratio for the broken covers.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 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.

Event Description

Manufacturer¿s reference number (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: 15083516
• MDR Text Key: 302324692
• Report Number: 9710055-2022-00302
• 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,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ARD568601998
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 07/25/2022; 08/25/2022
• Supplement Dates FDA Received: 08/19/2022; 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/26/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1