MAUDE Adverse Event Report: MAQUET SAS LUCEA 50; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARDLCA309004A

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 23rd february, 2021 getinge became aware of an issue with lucea 50 surgical light.The cover of light head was cracked and particles were missing.The issue was in line with photographic evidence.There was no injury reported, however, we decided to report the complaint in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination.

Manufacturer Narrative

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 lucea 50 surgical light.The cover of light head was cracked and particles were missing.The issue was in line with photographic evidence.There was no injury reported, however, we decided to report the complaint in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as particles cover were missing, and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.The cover is completely destroyed (broken in several parts).It is obvious that the light head was submitted to a strong mechanical shock.This is the only root cause of the case.We believe that overall the devices on the market are performing correctly.Given the circumstances we 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 50
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11378583
• MDR Text Key: 233555606
• Report Number: 9710055-2021-00076
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA309004A
• Device Catalogue Number: ARDLCA309004A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1