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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTECH SAS ROSA ONE; COMMON DEVICE NAME:
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MEDTECH SAS ROSA ONE; COMMON DEVICE NAME: Back to Search Results
Model Number ROSA ONE 3.1
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/10/2022
Event Type  Injury  
Event Description
At the beginning of the procedure, the robot registration went as usual, the frame registration error was 0.33 mm and the robot registration error 0.53 mm.After implantation of the fifth electrode, i found that 4/5 of the lengths of the electrodes had a systematic 5 mm error and we took an o-arc image, from which it was found that all but one electrode (4/5) were 5 mm too anterior to the plan.The electrode, which was designed to be oriented, was tipped slightly obliquely to the skull bone, the misaligned electrodes were all oriented at an angle of about 90 degrees to the skull bone.Anatomically, however, with the exception of one electrode, the other electrodes appeared to be still in place.It was decided that i made a new registration, after which the error seemed to be fixed.In a post-operative examination, based on the fusions made by the physicist, the electrodes are in place.At the end of the procedure, an electrode that was outside the anatomical area was replaced.When the screw was placed in the new position, next to the hole in the former drill, the threads of the screw crack through the bone, the screw sank intracranially along the external threads and had to be removed.The sinking of the screw inside the bone caused a small local bleeding into the brain tissue of the patient.Due to the complication, the electrode in question was thus not placed in the patient.There was no patient impact caused by those events.
 
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).
 
Manufacturer Narrative
A full analysis of the data logs has been performed and this analysis concluded that an inaccuracy is confirmed for four trajectories among eleven at the entry point as the error is over the specification limit of 2 mm maximum to 2.79 mm.No trend was found about the area and direction of the deviated electrodes.Regarding the first steps of the procedure, it was found that: the registration verification was not performed properly regarding to ifu instructions, notably, the registration accuracy could not be correctly verified and was validated with errors, both times.The pre-operative exam fusion, as well as the intra-operative fusion and post-operative fusion were not fully correct and were not properly adjusted by the user as recommended in the ifu.Additional question to the user permitted to confirm that the main issue was a lack of expertise about the image fusion.Although the ifu and the software contains all necessary warnings, information and tools to rework the incorrect fusion manually, an issue of the automatic fusion algorithm performance was still noted and will be addressed through the continuous improvement process of our products.Corrected data: b3 date of event b4 date of this report g3 date received by manufacturer h2 if follow-up, what type h3 device evaluated by manufacturer h6 adverse event problem h10 additional narratives/data.
 
Event Description
At the beginning of the procedure, the robot registration went as usual, the frame registration error was 0.33 mm and the robot registration error 0.53 mm.After implantation of the fifth electrode, i found that 4/5 of the lengths of the electrodes had a systematic 5 mm error and we took an o-arc image, from which it was found that all but one electrode (4/5) were 5 mm too anterior to the plan.The electrode, which was designed to be oriented, was tipped slightly obliquely to the skull bone, the misaligned electrodes were all oriented at an angle of about 90 degrees to the skull bone.Anatomically, however, with the exception of one electrode, the other electrodes appeared to be still in place.It was decided that i made a new registration, after which the error seemed to be fixed.In a post-operative examination, based on the fusions made by the physicist, the electrodes are in place.At the end of the procedure, an electrode that was outside the anatomical area was replaced.When the screw was placed in the new position, next to the hole in the former drill, the threads of the screw crack through the bone, the screw sank intracranially along the external threads and had to be removed.The sinking of the screw inside the bone caused a small local bleeding into the brain tissue of the patient.Due to the complication, the electrode in question was thus not placed in the patient.There was no patient impact caused by those events.
 
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Brand Name
ROSA ONE
Type of Device
COMMON DEVICE NAME:
Manufacturer (Section D)
MEDTECH SAS
432 rue du rajol
maugio, languedoc-roussillon 34130
FR  34130
Manufacturer (Section G)
MEDTECH SAS
432 rue du rajol
maugio, languedoc-roussillon 34130
FR   34130
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
9047414400
MDR Report Key13514578
MDR Text Key285625571
Report Number3009185973-2022-00008
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K200511
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00247
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 Received03/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/23/2020
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
Patient Outcome(s) Other;
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