MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568603999

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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.

Event Description

On (b)(6) 2021 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the housing was broken.Photographic evidence shows that plastic particles were missing.There was no injury reported, however, we decided to report the complaint in abundance of caution, as any particles falling off into sterile field or during procedure may cause contamination.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

On 15th february, 2021 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the housing was broken.Photographic evidence shows that plastic particles were missing.There was no injury reported, however, we decided to report the complaint in abundance of caution, as any particles 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 it was damaged and particles were missing, and it contributed to the event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: mechanical stress, environmental conditions (such a high temperature and humidity variations during transport and storage), use of inappropriate cleaning/disinfections products, or inappropriate cleaning and disinfection protocols.We believe that all remaining devices are performing correctly in the market.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.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.

• Brand Name: LUCEA 100
• 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: 11343513
• MDR Text Key: 232393366
• Report Number: 9710055-2021-00063
• 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
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568603999
• Device Catalogue Number: ARD568603999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1