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

Model Number COMPUTER FOR PRE-OP PLANNING

Device Problems Computer Software Problem (1112); Application Program Problem (2880); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that when trying to load in a large number of series from iqview into the software caused it to crash.Device history record review and complaint history review were not performed based on the low severity of this complaint.A full analysis of the data logs from the event has been performed, this analysis concluded that multiple crashes occurred during this case.Two occurred before exams loading from iq-view due to a software anomaly.The other crashes occurred after multiple reading errors of exams, unhandled by the software, due to an other software anomaly.The deletion of the temporary pacs folder was first compromised due to an other software anomaly, which occurred multiple times during the case.Deleting all unsupported exams directly in iq-view and selecting only exams of interest solved the issue.

Event Description

The company field service engineer (fse) received a phone call from surgeon on (b)(6) 2019 as he was planning his first case.Fse had already changed configuration issues in iqview previously due to configuration issues.The surgeon reported that he had tried to load in a large number of series from iqview into the rosa software, causing it to crash (message "rosanna.Exe stopped working").Whenever he subsequently tried to load in anything from iqview into the rosa software, the rosanna software continued to crash, even after clicking "yes" to delete files in the temporary pacs folder.The fse suspected that the rosa software was not correctly deleting from the temporary pacs folder.The fse directed the surgeon to delete out the series manually from the maintenance side.Another try also led to a crash.The surgeon rebooted the rosa software, and noticed that the series he had previously loaded were still listed under the "network" tab on iqview.After deleting these series off of the iqview side, he was able to load his series (ct and mri) without any issues.This issue did not occur during a procedure and there was no patient involvement.

• 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: 9595134
• MDR Text Key: 196074364
• Report Number: 3009185973-2020-00009
• 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
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: COMPUTER FOR PRE-OP PLANNING
• Device Catalogue Number: ROSAS00349
• Device Lot Number: 3.1.0.1276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2018
• 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 Sequence Number: 1