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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
Catalog Number ARDLCA309007A
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The issue is still being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On (b)(4) 2019 maquet (b)(4) became aware of an issue with one of devices- lucea 100. As it was stated, the cover of the light head is cracked and it resulted in missing plastic particles. 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 be a source of contamination.
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
(b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
(b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer reference number: (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand NameLUCEA 100
Type of DeviceLAMP, 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 
0332382587
MDR Report Key8734474
MDR Text Key149193521
Report Number9710055-2019-00206
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Inspection
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberARDLCA309007A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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