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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
Model Number VCS64SF - ARDVCS209006A
Device Problems Corroded (1131); Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
On (b)(6) 2021 getinge became aware of an issue with one of surgical lights, volista access. As getinge was informed, the rust occurred on the device and the paint was chipping off from surgical light. It was confirmed by the photographic evidence. We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
 
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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 Key12524645
MDR Text Key273075364
Report Number9710055-2021-00307
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVCS64SF - ARDVCS209006A
Device Catalogue NumberARDVCS209006A
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 Received10/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/11/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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