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

Model Number LAPTOP COMPUTER

Device Problem Problem with Software Installation (3013)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Udi# : (b)(4).The device has not been evaluated yet for investigation purpose.Once the evaluation is performed, a follow-up medwatch report will be submitted.

Event Description

It was reported that the robot, and planning station were not able to query/retrieve from pacs.

Manufacturer Narrative

A full analysis of the data logs has been performed and concluded that the complaint describes two main events and a series of tests, troubleshooting and assumptions.In order to focus on the reliable information for the investigation; the analysis may focus on: the events which occured on the (b)(6) 2020: the failure of the images retrieval.The troubleshooting performed at the first week of october.However: nor logs from laptop, neither logs from iq-view were provided for the event date for pacs issue.Only a set of iq-view logs were provided for the troubleshooting attempted in october.This analysis concluded that the available information do not permit to determine the cause for the pacs issue.The event described in the complaint is confirmed.

Event Description

It was reported that the robot and planning station were not able to query/retrieve from pacs.

• 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: 10799524
• MDR Text Key: 215611936
• Report Number: 3009185973-2020-00268
• 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
• Type of Report: Initial,Followup
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: LAPTOP COMPUTER
• Device Catalogue Number: ROSAS00503
• Device Lot Number: 3.1.4.1650
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1