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U.S. Department of Health and Human Services

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

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MAQUET SAS VOLISTA LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Catalog Number ARD568811911
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(4) 2019 maquet sas became aware of an issue with one of surgical lights- volista 600. As it was stated, the crack on the bracket was found. There was no injury reported however we decided to report the issue in abundance of caution as the crack may lead to the detachment of the light head and it may lead to a serious injury or worse. Manufacturer reference number (b)(4).

 
Manufacturer Narrative

The issue is still being investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
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. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
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Brand NameVOLISTA
Type of DeviceLIGHT, SURGICAL, CEILING MOUNTED
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
PASCAL JAY - 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 Key8556127
MDR Text Key143592410
Report Number9710055-2019-00161
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeNL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberARD568811911
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 Received04/05/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/26/2014
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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