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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET SAS XS SINGLE FLAT SCREEN HOLDER HOLDER, CAMERA, SURGICAL

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MAQUET SAS XS SINGLE FLAT SCREEN HOLDER HOLDER, CAMERA, SURGICAL Back to Search Results
Model Number ARD567506996
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The issue is still being investigated by manufacturing site. Device not returned to manufacturer.
 
Event Description
On 17th june, 2019 maquet sas became aware of an issue with one of the devices - xs single flat screen holder. As it was stated, handle was missing from the device. There was no injury reported and the circumstances of the issue are unknown. However considering the worse case scenario the missing part could detach from the device and fall off into the sterile field, therefore we decided to report this issue in abundance of caution as it might be a source of contamination.
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
(b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer reference number (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer referenece number: (b)(4).
 
Manufacturer Narrative
The issue is still being investigated by manufacturing site.
 
Event Description
Manufacturer reference number (b)(4).
 
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Brand NameXS SINGLE FLAT SCREEN HOLDER
Type of DeviceHOLDER, CAMERA, 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 
0332382587
MDR Report Key8789229
MDR Text Key150992728
Report Number9710055-2019-00216
Device Sequence Number1
Product Code FXR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Remedial Action Repair
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberARD567506996
Device Catalogue NumberARD567506996
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/02/2012
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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