MAUDE Adverse Event Report: MEDTECH SA ROSA BRAIN COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA BRAIN

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Code Available (3191)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

Udi# : (b)(4). The device has not been evaluated yet for investigation purpose. Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

An airo ct was taken of the patient in the prone position. The ct was transferred onto a usb and loaded onto the robot. An automatic merge was performed; however, the merge was unsuccessful. It appeared that the ct was fully rotated on the axis and over 45 degrees off from the mri. The merge was performed twice more with cutting extra slices on the top and bottom of the set; however, this did not work. A semi-automatic merge was attempted with 5 points, but this made the image worse. It was confirmed that the airo options for prone and axial ct had been selected. Another mri was loaded onto the patient (this one of a sagittal view) and merged to the original mri on the plan. The ct was then merged to this second mri and was able to merge successfully. The surgeon was upset that the software could not perform the automatic merge itself and that there was no option to align the two images partially and allow the software to do the automatic merge from that point. A delay of over an hour occurred during this time while the patient was under anesthesia. This was an rns case.

• Brand Name: ROSA BRAIN
• Type of Device: COMPUTER-ASSISTED SURGICAL DEVICE
• Manufacturer (Section D): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer (Section G): MEDTECH SA; zac eureka; 900 rue du mas de verchant; montpellier, languedoc-roussillon 34000 ; FR 34000
• Manufacturer Contact: jay sharma ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8795376
• MDR Text Key: 151195878
• Report Number: 3009185973-2019-00244
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172444
• Number of Events Reported: 1
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROSA BRAIN
• Device Catalogue Number: N/A
• Device Lot Number: 3.0.0.21
• 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 Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 07/16/2019 Patient Sequence Number: 1