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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 3.1
Device Problems Incorrect Measurement (1383); Malposition of Device (2616)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2022
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 surgeon had a merge issue on (b)(6) 2022.O-arm scan was taken after fiducials were placed and it was merged to an mr scan.The o-arm ct came over with incorrect orientations in each anatomical plane (the slices and planes did not correlate).The o-arm scan had to be rotated to get it to the correct orientation, the merge was recalculated, and it looked good enough for surgeon approval.Registration had rms of 0.42.Procedure was conducted without any navigation issues.The surgeon office reviewed the accuracy by merging the post operative ct to the pre operative plan on mr.13/16 leads were off trajectory according to post operative ct to plan merge.Every errant lead was good length and followed trajectory path but was translated 2-3mm to the side.No common pattern of these leads being off in one direction or plane was found.It was sporadic.
 
Manufacturer Narrative
A full analysis of the data logs has been performed and this analysis concluded that the robot operated as expected and the trajectories were properly placed in relation to the registered exam although that the registration accuracy was not checked as recommended on the instructions for use.However, the fusion analysis revealed that the registered exam merged to the mri plan was validated with rotational errors on multiple planes.Therefore, the inaccurate placement of the electrodes in the brain is confirmed for the most anterior ones.The automatic fusion did not provide a correct result and required to be re-adjusted.Although that the device worked within specifications, this issue will be addressed through the continuous improvement process of our products.The recalculate function was used to get a better result and helped on that purpose but the result was not re-adjusted again and validated with rotational errors.This is the cause for the inaccuracies observed.
 
Event Description
The surgeon had a merge issue on (b)(6) 2022.O-arm scan was taken after fiducials were placed and it was merged to an mr scan.The o-arm ct came over with incorrect orientations in each anatomical plane (the slices and planes did not correlate).The o-arm scan had to be rotated to get it to the correct orientation, the merge was recalculated, and it looked good enough for surgeon approval.Registration had rms of 0.42.Procedure was conducted without any navigation issues.The surgeon office reviewed the accuracy by merging the post operative ct to the pre operative plan on mr.13/16 leads were off trajectory according to post operative ct to plan merge.Every errant lead was good length and followed trajectory path but was translated 2-3mm to the side.No common pattern of these leads being off in one direction or plane was found.It was sporadic.
 
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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 Key13993383
MDR Text Key288489938
Report Number3009185973-2022-00025
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
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 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00203
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
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/08/2018
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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