MAUDE Adverse Event Report: MEDTECH SA ROSA ONE 3.1; COMPUTER-ASSISTED SURGICAL DEVICE

Model Number ROSA ONE 3.1

Device Problem Computer Software Problem (1112)

Patient Problems No Information (3190); No Code Available (3191)

Event Date 03/05/2020

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.(b)(4).(b)(4).

Event Description

The field service engineer was present for an ablation case at (b)(6) with dr.(b)(6).Surgeon wanted to use frame registration, so placed the frame on the patient and took an o-arm spin with the patient already hooked to the rosa.When the fse and surgeon tried to mark the points for frame identification, the error message that the markers were marked incorrectly came up after hitting propagation.A small amount of the zs on the radiolucent box was missing from the scan (preop o-arm), so cr and surgeon decided to take another scan and make sure that those zs were all present.However, the same issue occurred with the second scan (preop 2).Surgeon and cr noted that there was a lot of noise and dropout in the scan that seemed to affect the shape/quality of the markers in the o-arm scan.However, nothing unusual was in the scan and a similar setup had been used previously without any problems.Surgeon ended up using fiducial registration from the pins of the leksell frame to move forward with the case.Delay to case 2 hours, patient was already under anesthesia, no patient impact.

Event Description

The field service engineer was present for an ablation case at bjc with dr.(b)(6).Surgeon wanted to use frame registration, so placed the frame on the patient and took an o-arm spin with the patient already hooked to the rosa.When the fse and surgeon tried to mark the points for frame identification, the error message that the markers were marked incorrectly came up after hitting propagation.A small amount of the zs on the radiolucent box was missing from the scan (preop oarm), so cr and surgeon decided to take another scan and make sure that those zs were all present.However, the same issue occurred with the second scan (preop 2).Surgeon and cr noted that there was a lot of noise and dropout in the scan that seemed to affect the shape/quality of the markers in the o-arm scan.However, nothing unusual was in the scan and a similar setup had been used previously without any problems.Surgeon ended up using fiducial registration from the pins of the leksell frame to move forward with the case.Delay to case 2 hours, patient was already under anesthesia, no patient impact.

Manufacturer Narrative

Device history record review and complaint history review did not identify contributing factors.A full analysis of the data logs and of the patient folder has been performed.This analysis concluded that the error is caused by the software¿s mismanagement of an exam which was acquired with a leksell frame rotation.There is indication of deviations from the ifu during the reported event, that subsequently led to the reported issue: - the ifu provides the necessary information regarding the patient's head fixation system.In this case, the user attached the patient's head with an unexpected fixation system: a starburst adaptor was used to connect the leksell frame to the rosa mayfield head holder adaptor.- regarding the acquisition protocol, it stipulates that axial acquisition is required for the imagery used during the registration.In this case, the head of the patient was not in the correct position during the acquisition of the ct scan: the patient head was rotated.Note for h6 patient code: in the initial report 3009185973-2020-00112 the code 3190 was chosen by error, it is corrected in this report with the code 3191.D4 unique identifier (udi) #: (b)(4).

• Brand Name: ROSA ONE 3.1
• 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: 9911014
• MDR Text Key: 186376803
• Report Number: 3009185973-2020-00112
• 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: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ROSA ONE 3.1
• 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: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other