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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS LAMP, SURGICAL

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MAQUET SAS VOLISTA ACCESS LAMP, SURGICAL Back to Search Results
Catalog Number ARD568831961
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On 5th may, 2022 getinge became aware of an issue with one of the surgical lights - volista. It was stated that paint was peeling. We decided to report the issue in abundance of caution as any paint particles falling off into sterile field or during procedure may cause contamination.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
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Brand NameVOLISTA ACCESS
Type of DeviceLAMP, SURGICAL
Manufacturer (Section D)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer (Section G)
MAQUET SAS
parc de limere
avenue de la pomme de pin
ardon
Manufacturer Contact
pascal jay
parc de limere
avenue de la pomme de pin
ardon 
MDR Report Key14335704
MDR Text Key291205766
Report Number9710055-2022-00149
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberARD568831961
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/28/2020
Is the Device Single Use? No
Type of Device Usage Reuse

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