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

Model Number ARD568601997

Device Problem Crack (1135)

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

Event Date 01/07/2022

Event Type  malfunction  

Event Description

On 7th january, 2022 getinge became aware of an issue with one of examination lights - lucea 40.As it was stated, the lamp have broken housing.Photo evidence showed, that some particles were 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 might cause a contamination.

Manufacturer Narrative

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

Manufacturer Narrative

Getinge became aware of an issue with examination light - lucea 40.As it was stated, the lamp has broken housing.Photo evidence showed that some particles were 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 might cause a contamination.Based on ssu technician statement, some of the affected devices were modified and brought back to service.It was established that when the event occurred, the surgical light did not meet its specification due to cracks and missing particles from covers, which contributed to the event.Provided information do not indicate if upon the event occurrence the device was being used for patient treatment.Review of received customer product complaints related to investigated issue, revealed that there were no injuries to a user nor to a patient or operator when this particular malfunction occurred.We can assume that the failure ratio of cracks and missing particles on lucea 10/40 devices is low.As stated by subject matter expert at manufacturer¿s, cracks were detected at the edge of fixing holes of transparent housing and handle interface were probably caused by the incompatibility of the cleaning protocol or an abnormal use.The user manual for lucea 10/40 describes how to clean and disinfect the light heads.This document includes some of the recommended and prohibited products.In order to avoid mechanical stresses applied on the transparent housing during use the user manual mentions to handle the light by the handle.To prevent similar event, the same user manual mentions to check the light heads during daily inspection.We believe the related devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident would 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 reference number (b)(4).

Manufacturer Narrative

A follow-up report is required due to new information received.The correction of d4 catalog # and version of model # deems required.This is based on the internal evaluation.Previous catalog #:ardlca209021c.Corrected catalog #:ard568601997.Previous version or model #:ardlca209021c.Corrected version or model #:ard568601997.

Event Description

Manufacturer 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: 13423138
• MDR Text Key: 284868232
• Report Number: 9710055-2022-00037
• Device Sequence Number: 1
• Product Code: KZF
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• 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: 03/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1