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

Model Number ROSA ONE

Device Problem Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 10/02/2020

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. Udi # (unique identifier (udi) #: (b)(4).

Event Description

Company clinical representative (cr) was present for a monteris ablation case. The surgeon planned one trajectory for a fairly superficial lesion in the parietal lobe. Fiducial registration was performed by getting an o-arm scan and merging it to the preoperative mri. Both surgeon and cr looked at the merge and confirmed accuracy. After placing the trajectory, the patient was detached from rosa and the mri machine was brought in to begin the ablation. When the first intraoperative mri was taken, however, it showed that the trajectory was several millimeters inferior than the planning target point. As a result, surgeon was not able to ablate as much as the lesion as he wanted. Surgeon and cr again looked at the merge between the o-arm scan and the preoperative mri and did not believe that the merge could have caused the inaccuracy. Surgeon did not notice any head shift, the trajectory did not seem to skive during drilling or bolt placement, and the fiducial registration gave a good rms value that both the cr and surgeon found acceptable. The intraoperative mri scan showing the placement of the fiber would not merge correctly to the preoperative mri, but the cr retrieved it for the cht team to try to merge into the plan themselves. No known impact to patient, error occurred after first incision and patient was already under anesthesia, no delay to case.

• Brand Name: ROSA ONE
• 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: 10654601
• MDR Text Key: 210657893
• Report Number: 3009185973-2020-00260
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200511
• 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: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.4.1650
• 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: 01/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• 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: 10/09/2020 Patient Sequence Number: 1