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U.S. Department of Health and Human Services

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

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MAQUET SAS VOLISTA STANDOP LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARD5688111910
Device Problems Crack (1135); Material Fragmentation (1261)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). We are aware that this is past the 30 day deadline for reporting. The service unit forwarded the information to the manufacturer regarding the issue with a delay. We have reminded them to review fda reporting guidelines in order to prevent this from happening again. The issue is being investigated by manufacturing site.

 
Event Description

On 4th december, 2018 maquet (b)(4) became aware of an issue with one of surgical lights- volista. As it was stated, the problem with crack on the fork and paint chip occurred. There was no injury reported; however, we decided to report the issue based on the potential as any paint particle falling off into sterile field or during "prcedure" might be a source of contamination. 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).

 
Manufacturer Narrative

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

 
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 investigated by manufacturing site. (b)(4). Exemption # e2018005. (b)(4).

 
Event Description

Manufacturer reference number (b)(4).

 
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Brand NameVOLISTA STANDOP
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 Key8271772
MDR Text Key134211500
Report Number9710055-2019-00019
Device Sequence Number1
Product Code FSY
Combination Product (Y/N)N
Reporter Country CodeAR
PMA/PMN NumberK130513
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 09/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberARD5688111910
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 Received12/04/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/09/2014
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: 01/23/2019 Patient Sequence Number: 1
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