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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 ARD567910992
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation. Device not returned to manufacturer.
 
Event Description
On (b)(6),getinge became aware of an issue with one of surgical lights - volista access. As getinge was informed, the paint was chipping off from surgical light. 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.
 
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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 Key12347764
MDR Text Key267446707
Report Number9710055-2021-00287
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodePK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 11/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberARD567910992
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/11/2014
Is the Device Single Use? No
Type of Device Usage Reuse

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