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U.S. Department of Health and Human Services

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

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MAQUET SAS VOLISTA STANDOP LAMP, SURGICAL Back to Search Results
Model Number ARD568821962
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
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) 2021 getinge became aware of an issue with one of the surgical lights - volista. It was stated that during surgery paint was peeling from fork and fell into sterile field. 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 STANDOP
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 Key13150547
MDR Text Key283138861
Report Number9710055-2022-00002
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568821962
Device Catalogue NumberARD56821962
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/22/2017
Is the Device Single Use? No
Type of Device Usage Reuse
Removal/Correction NumberZ-1308-2022

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