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

Model Number ARDLCA219004A

Device Problems Crack (1135); Detachment of Device or Device Component (2907)

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

Event Date 07/26/2021

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 100.The headlight and underside covers are damaged - particles missing.The issue was confirmed by the photographic evidence.There was no injury reported however we decided to report the issue in abundance of caution as any particles falling may lead to contamination.

Event Description

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

Manufacturer Narrative

On 26th july 2021 getinge became aware of an issue with surgical light ¿ lucea 100.The headlight and underside covers were damaged resulting in missing particles.The issue was confirmed by the video evidence.The facility was visited by the getinge representative who confirmed the received allegation.The quotation was submitted for the required spare parts and technician was waiting for po.It was established that when the event occurred, the surgical light did not meet the manufacturer¿s specification as the headlight and underside covers were damaged, resulting in missing particles and it contributed to the event.The investigated issue was discovered during daily checking, therefore the device was not being used for patient treatment when the event took place.After reviewing the information provided for the customer product complaints investigated here, the trend is increasing.However, we can assume that the complaint rate is low (0,34%).Cracks located on the light head lower covers, at the edge of the on/off button, were detected during daily visual inspection, as recommended by the user manual.If the described failure occurs, the user can visually detect it during the daily checks to be performed prior to each use, or during preventive maintenance.In this case, the user would contact a getinge representative to replace the defective covers of the affected device.For cleaning, the ifu informs the user to not use aggressive and abrasive products.During disinfection, it is prohibited to spray the disinfectant solution directly on the device and to use inappropriate disinfectants.To prevent any incident the lucea50-100 user manual mentions : ¿check the light heads for chipped paint, impact marks and any other damages¿ during the daily inspections (40886-lucea_50-100_user_manual ¿ chapter 4.1 ¿ daily inspections before use, page 26).Based on the investigations the most probable root cause of the cracks is a combination of different factors: mechanical stress, use of inappropriate cleaning/disinfection products, or inappropriate cleaning and disinfection protocols.We believe that if the manufacturer recommendation would have been followed the incident would have been avoided.The correction of d4 catalog # field deems required.This is based on the internal evaluation.Previous d4 catalog # ardlca219004a.Corrected d4 catalog # ard569068999.

• Brand Name: LUCEA 100
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12279143
• MDR Text Key: 265138929
• Report Number: 9710055-2021-00257
• Device Sequence Number: 1
• Product Code: FTD
• 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: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ARDLCA219004A
• Device Catalogue Number: ARD569068999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/23/2021
• Patient Sequence Number: 1