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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) #: (b)(4). A full analysis of the data logs has been performed. This analysis concluded that the inaccuracy at the entry point is confirmed for all fourteen trajectories implanted. The cause for the inaccuracy could not be determined. No dysfunction was identified on the device. The device passed the maintenance tests that were performed before and after the case.

Event Description

The company representative (cr) assisted the surgeon for an seeg case using bs (b)(4). After the case was complete, a few post-op scans were obtained from the o-arm, and merged into the software. The merge appeared to have worked correctly. It was found that all of the laterally placed electrodes appeared to be off at entry by more than 4mm. The surgeon noted that a shift most likely did not occur, the patient was very secure with the leksell frame, so the surgeon is worried that the accuracy was due to something with rosa. The two insular electrodes appeared to be more accurate, and these were placed obliquely (versus laterally). Contactless registration was used, and there were no errors during the registration, everything appeared to be correct. Verification also passed. The cr looked at the most recent preventive maintenance forms for the last four accuracy tests on form f-019, and it appears the x error appears to be around 2mm for each test, and then y and z appear to be anywhere from 1. 5-1. 7mm of error. The serial number for the laser is (b)(4), so the laser itself is almost 5 years old. The surgeon requested that an investigation be performed asap, since the surgeon is concerned about accuracy for their future cases.

• 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: 11869238
• MDR Text Key: 265352423
• Report Number: 3009185973-2021-00126
• 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

• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: No
• 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?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• 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