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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 ARD568805901
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/30/2020
Event Type  malfunction  
Manufacturer Narrative
Issue is being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On 30th july, 2020 getinge became aware of an issue with one of surgical lights - volista access. As it was stated, the circlip inside the sterilizable handle broke. There was no injury reported however we decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may lead to 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 Key10361502
MDR Text Key201563823
Report Number9710055-2020-00246
Device Sequence Number1
Product Code FTD
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD568805901
Device Catalogue NumberARD568805901
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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