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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
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/17/2018
Event Type  Malfunction  
Manufacturer Narrative

We are aware that this is past the 30 day deadline for reporting. The service unit forwarded the information late due to error in submission. The issue is being investigated by manufacturing site. (b)(4).

 
Event Description

On (b)(6) 2018 maquet (b)(4) became aware of an issue with one of surgical lights- volista. As it was stated, 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.

 
Event Description

(b)(4).

 
Manufacturer Narrative

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

 
Event Description

Manufacturer's reference number (b)(4).

 
Manufacturer Narrative

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

 
Event Description

Manufacturer's reference number (b)(4).

 
Manufacturer Narrative

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

 
Event Description

Manufacturer's reference number (b)(4).

 
Manufacturer Narrative

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

 
Event Description

Manufacturer's 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 Key8362187
MDR Text Key138144801
Report Number9710055-2019-00043
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Inspection
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/17/2018
Was Device Evaluated By Manufacturer? No
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: 02/22/2019 Patient Sequence Number: 1
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