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 Known Impact Or Consequence To Patient (2692)

Event Date 01/14/2020

Event Type  malfunction  

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

Company field service director received a phone call from the surgeon. She was not happy with her recent procedure which was a redo from an aborted procedure from the previous week. Of the 14 electrodes she placed, 12 were measured 4 ¿ 6 mm deep from the intended target. A company field service engineer (fse) was in the operating room to assist in this very touchy procedure to lend his expertise. Between the fse, the surgeon and the pmt electrode rep they had agreed on calculations for the electrodes ahead of time ¿ and 12/14 electrodes were off. On the phone, the surgeon told that 2 other sites have the identical issue ¿ (b)(6) hospital, that the company field service director believe are using pmt electrodes. Surgeon told that prior to the 3. 1 software configuration, she had great results and no one was reporting issues for depth and now after the software, there are issues.

• 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: 9691565
• MDR Text Key: 200847518
• Report Number: 3009185973-2020-00036
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182417
• 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: 08/06/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/11/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.1.1295
• 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 Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2018
• 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