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

Model Number LAPTOP PLANNING STATION - DE

Device Problem Computer Software Problem (1112)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2021

Event Type  malfunction  

Manufacturer Narrative

Udi# : (b)(4).A full analysis of the data logs has been performed and permitted to conclude that the ct pre-operative exam loaded during the event caused the patient folder disappearance from the menu list due to the missing field 'series date'.This is a known software anomaly.Analysis showed that the event is confirmed.

Event Description

Patient folder was created on the laptop.After exporting to usb and closing the patient folder, the laptop didn¿t show the patient folder.Import from usb gave 'you want to overwrite' message.After overwriting and changing, exporting to usb again, patient folder still didn¿t show up on the laptop.Importing from usb also not possible.Patient folder was damaged.Since the usb still showed up, it was tried to import on robot.It didn¿t work, patient folder was damaged.Creating a new patient folder and importing a ct from usb, saving closing and trying to reload it from the robot, patient folder again didn¿t show up.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: 11249969
• MDR Text Key: 229301547
• Report Number: 3009185973-2021-00015
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LAPTOP PLANNING STATION - DE
• Device Catalogue Number: ROSAS00505
• 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
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2018
• 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