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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
Model Number 568811960
Device Problems Crack (1135); Material Fragmentation (1261)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/09/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On 9th october, 2018 maquet (b)(4) became aware of an incident with one of surgical lights- volista standop. As it was stated, the crack on fork was found and the paint chipping also occurred. There is no injury reported however we decided to report the issue in abundance of caution as any paint particle falling might be a source of contamination. 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. (b)(4). Exemption # e2018005. (b)(4).

 
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).

 
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. (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
orléans cedex 2
FR
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 Key8050726
MDR Text Key126654261
Report Number9710055-2018-00179
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK130513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/08/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number568811960
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 Received10/09/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/13/2014
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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