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

Model Number ARDLCA309004C

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.Device not returned to manufacturer.

Event Description

On 26th january, 2021 getinge became aware of an issue with lucea 100 surgical light.As it was stated, the cover was cracked.Photographic evidence shows that particles are missing.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 cause contamination.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Getinge became aware of an issue with lucea 50 surgical light.As it was stated, the cover was cracked.Photographic evidence shows that particles are missing.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 cause contamination.It was established that when the event occurred, the surgical light did not meet its specification as the light head was cracked and it contributed to the issue.There is no information if in the time of event the device was or was not being used for patient treatment.All maquet sas products comply with: o iec 60601-1 ed.2.0 & ed.3.0 ¿ general requirements for basic safety and essential performance o iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis o disinfection product test: maquet sas described how to perform the material resistance test in the working instruction ref.Fl 007 to avoid degradation of the shell it is recommended to respect the contact time and to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.In 2015, a design change improved the braking system and the mechanical durability of the upper cover.In user manual 01741en09, there is an information included to check the device for impact marks and any other damage.To prevent similar incident, it is recommended to respect the cleaning instructions avoiding: - prolonged exposure to detergents and disinfectants solutions - high concentrations - prohibited products.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: LUCEA
• 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: 11313707
• MDR Text Key: 231370944
• Report Number: 9710055-2021-00058
• 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: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ARDLCA309004C
• Device Catalogue Number: ARDLCA309004C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1