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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS XTEN LIGHT, SURGICAL, CEILING MOUNTED

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MAQUET SAS XTEN LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number LUSX10DDFV
Device Problem Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Type  Malfunction  
Manufacturer Narrative

The issue is being investigated by manufacturing site. (b)(4).

 
Event Description

On 9th march, 2018 maquet (b)(4) became aware of an incident with the one of surgical lights- xten. As it was stated the elbow cover fell off. We do not have any information about circumstances of the event however we decided to report the issue in abundance of caution. (b)(4).

 
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Brand NameXTEN
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
orléans cedex 2
FR
Manufacturer (Section G)
FREDERIC LELEU - MAQUET SAS
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
FR 45074
Manufacturer Contact
parc de limère
avenue de la pomme de pi
orléans cedex 2 45074
0332382587
MDR Report Key7395992
MDR Text Key104734583
Report Number9710055-2018-00014
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
PMA/PMN NumberK040735
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberLUSX10DDFV
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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