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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 ARD568806905
Device Problems Crack (1135); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
On 30th january, 2024 getinge became aware of an issue with one of surgical lights - volista access 600.As it was stated, two sides covers and a tab were missing.The designated complaint unit employee confirmed based on photographic evidence the two sides covers and the dust covers were not present on the device and have some missing particles.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 in case of reoccurrence.
 
Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
 
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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 Key18702563
MDR Text Key335354572
Report Number9710055-2024-00147
Device Sequence Number1
Product Code FSY
Combination Product (y/n)N
Reporter Country CodeFR
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 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberARD568806905
Device Catalogue NumberARD568806905
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/30/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/21/2023
Is the Device Single Use? No
Type of Device Usage Reuse
Patient Sequence Number1
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