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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE
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MEDTECH SA ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Data Problem (3196)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.(udi) #: (b)(4).
 
Event Description
When loading in the oarm ct scan to merge with the mri for bone fid reg, the scan showed up on usb then clicking on it to see the series description and the exam disappeared.User was able to go into the iqview application and pull it over from filesystem off user usb so there was no delay in surgery.
 
Event Description
When loading in the oarm ct scan to merge with the mri for bone fid reg, the scan showed up on usb then clicking on it to see the series description and the exam disappeared.User was able to go into the iqview application and pull it over from filesystem off user usb so there was no delay in surgery.
 
Manufacturer Narrative
Analysis concluded that the exam disappearance from the usb list was probably due to the fact that windows detected an issue with the usb, tried to repair it automatically and modified the file.The file did not appear anymore in the rosa list because it had been modified.It could be loaded through iqview without any issue after repair.
 
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Brand Name
ROSA ONE
Type of Device
COMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SA
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR  34000
MDR Report Key11093661
MDR Text Key227827545
Report Number3009185973-2020-00334
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.4.1650
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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