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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS VOLISTA ACCESS; LIGHT, SURGICAL, CEILING MOUNTED
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MAQUET SAS VOLISTA ACCESS; LIGHT, SURGICAL, CEILING MOUNTED Back to Search Results
Model Number ARDVCS209005A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2024
Event Type  malfunction  
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
 
Event Description
On 27th april, 2024 getinge became aware of an issue with one of surgical lights - volista access.It was stated and also confirmed by photographic evidence, the spring arm rod was broken.There was no injury reported, however, we decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or serious injury.
 
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Brand Name
VOLISTA ACCESS
Type of Device
LIGHT, SURGICAL, CEILING MOUNTED
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 Key19211705
MDR Text Key341502658
Report Number9710055-2024-00309
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARDVCS209005A
Device Catalogue NumberARDVCS209005A
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/30/2022
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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