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".

• 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: 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

0 Patients were 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2018
• 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