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.

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), 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.

Manufacturer Narrative

A full analysis of the data logs and of the patient folder has been performed.This analysis concluded that every electrodes positioning is accurate at the entry point.Twelve electrodes among the fourteen are implanted more than 2mm beyond the target point.The analysis of the spreadsheet from surgery permitted to determine that there is a gap between the calculated lengths of electrode to implant and the actual ones.Additional values were provided by pmt representative as pmt equipment was used for this surgery.Notably, different types of bolt caps ¿ including a new release - and a pmt cannula adaptor were used during the case.Using the function 'distance to target' - essential for the electrode length detection - requires to install a cannula adaptor compatible to rosa one brain.The pmt cannula adaptor is not in the list of the compatible devices for the rosa one device.Results of the reproduction of the seeg procedure performed the (b)(6) 2020, on a phantom permitted to demonstrate that the software behaved as expected on the event day.Therefore, the cause for the error in depth remains unknown.The change in the design of pmt bolt caps and the pmt method of calculation for the electrode length are part of the most probable hypothesis.It was found during the investigation that the registration verification was not completed entirely.A review of the user manual was made and it provides the necessary information to perform a correct registration verification.Seven anatomical points have to be checked and important errors has to be visually checked on 2d views.It confirms that the registration verification was incomplete in this case.It was found during the investigation that a known software anomaly occurred for the verification of one point without impact on the accuracy of the surgery.

• 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
• 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
• PMA/PMN Number: K182417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.1.1295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1