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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE

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MEDTECH SAS ROSA ONE; COMPUTER-ASSISTED SURGICAL DEVICE Back to Search Results
Model Number ROSA ONE
Device Problem Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
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.Unique identifier (udi) #: (b)(4).
 
Event Description
The brain robot has a bad accuracy.There is an error of 4 mm in seeg trajectories and depth calculation.
 
Manufacturer Narrative
A full analysis of the data logs has been performed and concluded that an inaccuracy between 5 and 9 mm was confirmed for all fifteen trajectories.The trajectories are all deviated in the same direction, which could be consistent with a movement of the head that would have happened before the first trajectory.The following elements may have contributed to the inaccuracy: the user did not collect the points again with the robot arm after adjusting them on the image, as recommended.The laser scanning zone on the matching frame is small.The fusion of the pre-operative ct with the pre-operative mri was not completely accurate.No device malfunction was found during analysis.A post-operative maintenance showed no issue with the robot or the registration tool.
 
Event Description
The brain robot has a bad accuracy.There is an error of 4 mm in seeg traejctories and depth calculation.
 
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Brand Name
ROSA ONE
Type of Device
COMPUTER-ASSISTED SURGICAL DEVICE
Manufacturer (Section D)
MEDTECH SAS
432 rue du rajol
mauguio, languedoc-roussillon 34130
FR  34130
Manufacturer (Section G)
MEDTECH SAS
432 rue du rajol
mauguio, languedoc-roussillon 34130
FR   34130
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key13755395
MDR Text Key288030836
Report Number3009185973-2022-00022
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00218
Device Lot Number3.1.5.28
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/14/2022
Initial Date FDA Received03/14/2022
Supplement Dates Manufacturer Received04/21/2022
Supplement Dates FDA Received04/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A
Patient Sequence Number1
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