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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 ARD568603999
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/29/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On 29th september 2021 getinge became aware of an issue with lucea 100 surgical light. Initially claimed issue was not considered as safety related. However, during visit to perform verification in customer¿s facility on (b)(6) 2021 it was detected that the crack of cover led to 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 cause contamination.
 
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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 
MDR Report Key12751360
MDR Text Key280110384
Report Number9710055-2021-00345
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberARD568603999
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/31/2014
Is the Device Single Use? No
Type of Device Usage Reuse

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