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

Model Number ARDLCA309004A

Device Problem Detachment of Device or Device Component (2907)

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

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) 2021 getinge became aware of an issue with surgical light ¿ lucea 50.The cover is damaged - particles missing.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling may lead to contamination.

Manufacturer Narrative

Additional information will be provided upon results of investigation.

Event Description

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

Event Description

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

Manufacturer Narrative

On 13th august 2021 getinge became aware of an issue with surgical light ¿ lucea 50.The cover was damaged, resulting in missing particles.There was no injury reported, however we decided to report the issue in abundance of caution as any particles falling may lead to contamination.New parts for replacement were ordered to solve the issue.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification as the covers were damaged, resulting in missing particles and it contributed to the event.It is unknown if the device was being used for patient treatment when the issue occurred.Taking into consideration the install base for lucea 50/100 surgical lights, comparing to the number of complained devices, the failure ratio is low.Subject matter expert investigated the issue.Unfortunately, due to limited details obtained regarding the technical deficiency it was not possible to establish the exact root cause.However, based on the available data, the likely root cause is considered as misuse.We believe the related devices are performing correctly in the market.

• 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: 12364086
• MDR Text Key: 268026631
• Report Number: 9710055-2021-00289
• Device Sequence Number: 1
• Product Code: FSS
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARDLCA309004A
• Device Catalogue Number: ARDLCA309004A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/26/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1