MAUDE Adverse Event Report: MAQUET SAS LUCEA 50/100; LAMP, SURGICAL

Model Number ARD569070999

Device Problems Corroded (1131); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022 getinge became aware of an issue with one of surgical lights - lucea 50/100.It was stated the cover of camera was broken and detached from headlight and the corrosion occurred on the main tube.We decided to report the issue in abundance of caution as any part or 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.Device not returned to manufacturer.

Event Description

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

Manufacturer Narrative

Getinge became aware of an issue with one of surgical lights - lucea 50/100.It was stated the cover of camera was broken and detached from headlight and the corrosion occurred on the main tube.We decided to report the issue in abundance of caution as any part or particles falling off into sterile field or during procedure may cause contamination.According to the information provided by getinge technician, the repair is completed - the requested part has been applied (ard368614998 - lower cover without a lower cover with fork - l 100).There is no information if the device was or was not being used for a patient¿s treatment upon the event occurrence.When reviewing reportable events for these types of issues we were able to establish that the failure ratio of issues related to detachment of cover or its particles is moderate and the failure ratio of the rust occurrence is very low.We have been able to confirm that the investigated issues have never led to serious injury or worse, to our knowledge.As stated by the subject matter expert, the mechanical shocks probably led to the rupture of one or several fixing tabs that may cause the detachment of the camera cover.To prevent any incident, the manufacturer¿s recommendation is to follow the instruction for use lucea 50/100 (ifu_lucea_50_100_01741 en10, page 23,26) as also stated by the subject matter expert, the photographic evidences show rust formation and paint peeling on the device.It can be observed that the degradation of the paint and corrosion are mostly localized on the retention areas which shows that the stagnation of liquid or cleaning agent residues have caused paint damages and appearance of rust.Peeling paint and rust formation were probably caused by: a stagnation of aggressive disinfectant and detergent products due to an inappropriate cleaning protocol.The presence of liquid water or an exposure to humid air due to a high relative humidity of the operating room.The instruction for use indicates the environmental condition for use, the relative humidity must be between 20% and 75%.To prevent any incident the instruction for use mentions to perform daily and monthly inspection in order to detect painting defects, impact marks or other damages.The instruction for use mentions not to clean the device under running water nor spray a solution directly onto the device.Certain cleaning products or procedures may damage the paintwork of the device, which may result in particles falling onto the surgical site during an operation.Fumigation methods are unsuitable for disinfecting the unit and must not be used.The instruction for use mentions to wipe with a dry cloth and to make sure no liquid residue is left on the device after cleaning.(ifu_lucea_50_100_01741 en10, pages 26-27, 46) to reduce the appearance of rust or the degradation of the surface, the technical manual or maintenance manual mentions in the preventive maintenance protocol to lubricate some parts of device.The instruction for use mentions not to use a damaged device because it may lead to a risk of injury for users or a risk of infection for patients.(technical manual 01742 en 05, page 187) we believe the related devices are performing correctly in the market.We also believe that if the manufacturer¿s recommendations had been followed the incident could 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.

• Brand Name: LUCEA 50/100
• Type of Device: LAMP, SURGICAL
• 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: 14642628
• MDR Text Key: 293711034
• Report Number: 9710055-2022-00204
• Device Sequence Number: 1
• Product Code: FTD
• 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
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD569070999
• Device Catalogue Number: ARD569070999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/19/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1