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Model Number ROSA ONE 3.1
Device Problems Computer Software Problem (1112); Unintended Collision (1429)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation of this event is in progress to determine the root cause of the event. Once the evaluation is completed, a follow-up medwatch report will be submitted. Unique identifier (udi) #:(b)(4). The investigation is on-going.
Event Description
During a procedure to place 13 electrodes for a seeg, the following events occurred: upon turning on the rosa robot, the emergency stop button was on when not pressed. The robot had to be turned off, unplugged and plugged back in. When the initial reference points were registered, it was not possible to correct them according to the usual procedure. The recalibration had to be redone and then, during the second attempt, a manual correction of the "blue points" by superimposing them on the "red ones" was performed. The robot then asked to revalidate all the points. During the laser scanning (wings of the nose and temples of the patient), the scanning of the left temple never ended, it was necessary to cancel the scanning of this zone, no cause was found. The other areas could be scanned normally. During the accuracy check, the mandatory points of the check procedure could be validated but only one additional check point could be validated. An error message was displayed after checking this point "the robot is in a singular position. The cooperative mode will be restarted in slow speed". The accuracy of the recalibration was correct. It was therefore decided to continue the procedure. The first 9 electrodes were positioned according to the procedure. During the implantation of the tenth electrode, no one was pressing the pedal and the mobility was set to "axial". The arm made a movement that was not at all in line with the trajectory. A piece of the coagulation electrode broke off in the patient's skull. According to our information, there were no clinical consequences for the patient after the seeg electrode placement surgery. This electrode #10 was therefore not implanted. Then, the 3 last electrodes implanted were reportedly off by ~5mm. During the regularly planned seeg electrode removal surgery, the surgeon successfully removed the part of the coagulation electrode sheath that fractured and remained implanted, as reported by the clinical services team after an additional follow-up discussion with the surgeon. No adverse consequence for the patient was reported other than the additional scar resulting from the trepanation of the skull that was needed to proceed.
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Brand NameROSA ONE
Manufacturer (Section D)
432 rue du rajol
900 rue du mas de verchant
mauguio, languedoc-roussillon 34130
FR 34130
Manufacturer (Section G)
432 rue du rajol
900 rue du mas de verchant
mauguio, languedoc-roussillon 34130
FR 34130
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
MDR Report Key12745744
MDR Text Key280008026
Report Number3009185973-2021-00179
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
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 03/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROSA ONE 3.1
Device Catalogue NumberROSAS00201
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? Yes
Date Device Manufactured06/21/2016
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