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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 ARDVST229039A
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- volista. As it was stated, the weld on the racket of the surgical light is cracked. There was no injury reported however we decided to report the issue in abundance of caution as the crack in the racket may lead to detachment of the light head and this may lead to an adverse event. (b)(4).

 
Manufacturer Narrative

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

 
Event Description

Manufacturer reference (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 Key8343123
MDR Text Key136609736
Report Number9710055-2019-00036
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK130513
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 03/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberARDVST229039A
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 Received10/16/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/14/2016
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 02/15/2019 Patient Sequence Number: 1
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