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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 100; LAMP, SURGICAL
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MAQUET SAS LUCEA 100; LAMP, SURGICAL Back to Search Results
Model Number ARDLCA219001A
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 lucea 100 surgical light.According to photographic evidence, the particles of cover were missing on the headlight.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 lead to contamination.
 
Event Description
Manfuacturer's reference number (b)(4).
 
Manufacturer Narrative
On (b)(6) 2021 getinge became aware of an issue with lucea 100 surgical light.According to photographic evidence, the particles of cover were missing on the headlight.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 lead to 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.Cracks were detected on the light head covers, at the edge of the on/off button.The user can visually detect the cracks 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 cover of the affected device (ard368614998 lower cover with fork).For cleaning, the ifu warns 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 daily inspections.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.
 
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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 Key11900429
MDR Text Key253137638
Report Number9710055-2021-00206
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberARDLCA219001A
Device Catalogue NumberARDLCA219001A
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/02/2021
Patient Sequence Number1
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