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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS LUCEA 100-50 LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS LUCEA 100-50 LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARDLCA219002A
Device Problems Crack (1135); 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 15th february, 2021 getinge became aware of an issue with lucea 100-50 surgical light. As it was stated, the covers of light heads were broken and particles were missing. Additionally, the cap on the fork was missing. There was no injury reported, however we decided to report the complaint in abundance of caution as any particles or parts falling off into sterile field or during procedure may cause contamination.

 
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Brand NameLUCEA 100-50
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
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 Key11348612
MDR Text Key232552067
Report Number9710055-2021-00065
Device Sequence Number1
Product Code FSY
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
Type of Report Initial,Followup
Report Date 03/16/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberARDLCA219002A
Device Catalogue NumberARDLCA219002A
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 Received02/18/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/19/2018
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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