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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 STANDOP
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of the surgical lights - volista standop. The fork bracket of this device became cracked. There was no injury reported. Since it may lead to the fall of paint chips, we decided to report the issue in abundance of caution, as any part falling might be a source of contamination. (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 most possible root cause has been established however, it needs to be confirmed. (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 Key7961323
MDR Text Key123676518
Report Number9710055-2018-00118
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,CONSUM
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 03/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSTANDOP
Device Catalogue NumberARD568812952
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 Received10/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/11/2013
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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