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

Model Number ROSA ONE

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2021

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.Udi# : (b)(4).

Event Description

After the endoscopy case today, the surgeon asked the clinical representative (cr) to check the pacs connection.He was not able any more to get images sent to iqview.The cr checked with pacs tech whats the issue.It was found that a bad network setup.No gateway entered over dhcp.Switching to static ip settings solved this.After this pacs tech was able to sent images.Iqview database didn´t show images.Iqview log showed access denied for iqview db.The cr checked on the harddisc and found dicom data, which was retrieved in dicom folder.Rosanna and iqview didn´t show these dicoms.System almost unusable like this.Planning over cd drive is extremely slow.Furthermore the surgeon had issues to load a patient from usb.Rosanna showed data to load, but when selecting to load, error message, dicom cannot be loaded because the patient name had a "ü".

Manufacturer Narrative

A detailed analysis of the device data logs from this event has been performed.This analysis concluded that the first issue of data retrieval from pacs occurred due to incorrect network settings.The issue of exams display through the software cannot be confirmed due to missing device data logs.Regarding the special characters used in germany, the unsupported letters are properly detected and a dedicated error message is communicated to the user.The instructions for use adequately indicate that special characters shall not be used in the file or folder names.

Event Description

After the endoscopy case today, the surgeon asked the clinical representative (cr) to check the pacs connection.He was not able any more to get images sent to iqview.The cr checked with pacs tech whats the issue.It was found that a bad network setup.No gateway entered over dhcp.Switching to static ip settings solved this.After this pacs tech was able to sent images.Iqview database didn´t show images.Iqview log showed access denied for iqview db.The cr checked on the harddisc and found dicom data, which was retrieved in dicom folder.Rosanna and iqview didn´t show these dicoms.System almost unusable like this.Planning over cd drive is extremely slow.Furthermore the surgeon had issues to load a patient from usb.Rosanna showed data to load, but when selecting to load, error message, dicom cannot be loaded because the patient name had a "ü".

• 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: 11698781
• MDR Text Key: 256560934
• Report Number: 3009185973-2021-00108
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K200511
• 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: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00209
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1