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

Model Number ROSA ONE

Device Problem Problem with Software Installation (3013)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2019

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 after the rosa one upgrade performed in december 2019.

Manufacturer Narrative

No data can be retrieved prior to the last software upgrade.As the reported issue is still occurring with the new version of the rosa software, it will be analyzed though the most recent complaint received for this device for the same issue.The event described in the complaint is non-verifiable.Corrected data: - b4 date of this report.- g4 date received by manufacturer.- h2 if follow-up, what type.- h3 device evaluated by manufacturer.- h6 event problem and evaluation codes.- h10 additional narratives/data.

Event Description

It was reported that the robot and planning station were not able to query/retrieve from pacs after the rosa one upgrade performed in (b)(6) 2019.

• 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: 10695508
• MDR Text Key: 211858792
• Report Number: 3009185973-2020-00262
• 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
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: ROSAS00203
• Device Lot Number: 3.1.3.1494
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1