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Model Number ROSA ONE
Device Problem Malposition of Device (2616)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2020
Event Type  Injury  
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. (b)(4).
Event Description
The following event occurred during a dbs case on (b)(6) 2020: following the implantation of two leads, utilizing the fhc stardrive for a dbs case, a post-op scan was taken while the patient was still under anesthesia, although disconnected from the robot, using the bodytom. The scan was transferred and merged to the mri on the rosa robot in order to confirm placement of the leads. After checking that the merger was accurate, it was found that when looking at the planned trajectories, that the right lead was 8mm shallow than the planned target (the entry point of the right lead was completely accurate). There was also no accuracy issues with the left lead. At this point, the surgeon determined that the right lead would need to be advanced the 8 mm on the right side, which would ultimately require the lead to be removed and replaced. Surgeon and the residents that were present believed that the lead had been retracted slightly when the watch-face had been placed on top to secure the lead, thus that the error had not been due to the robot, but rather user error. The plan was not altered and the patient was then reconnected to the rosa robot again using the leksell headframe adaptor. Registration was again performed utilizing bone fiducials and the most recent bodytom post-op scan. The surgeon then drove the rosa robot back to the right side trajectory where they again opened the patient's incision. At this point, when examining the lead the surgeon was able to see the mark that they had made on the lead with a marking pen was in fact above the watch-face indicating it had been somehow pulled out slightly. The lead was safely removed and the rosa robot was driven to the right trajectory (utilizing again the proper 160mm instrument length required for the fhc stardrive). The right lead was then replaced utilizing the microdrive and the surgeon then drove the robot to the home position. Following the closure, another post-op scan utilizing the bodytom was used. Merging the post-op scan to the mri, it was found that the lead had been accurately placed and now the right and left leads were accurate/at the planned target. Due to the surgeon's request to replace the lead, the surgery continued an extra 1 hr 45 min from the first post-op scan to the final post op scan. The patient was under prolonged anesthesia.
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Brand NameROSA ONE
Manufacturer (Section D)
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer (Section G)
zac eureka
900 rue du mas de verchant
montpellier, languedoc-roussillon 34000
FR 34000
Manufacturer Contact
jay sharma
1520 tradeport drive
jacksonville, FL 32218
MDR Report Key10367948
MDR Text Key205311371
Report Number3009185973-2020-00188
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberROSA ONE
Device Catalogue NumberROSAS00203
Device Lot Number3.1.1.1295
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2018
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 Treatment Data
Date Received: 08/05/2020 Patient Sequence Number: 1