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

Model Number ROSA ONE

Device Problem Unintended Collision (1429)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

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

During bone fiducial registration using leksell frame pins, pointer probe became stuck in position inside the right posterior leksell frame pin.Upon attempt to move from stuck location, emergency shutdown occurred.Patient was anesthetized during this error and successful registration followed power cycle.Delayed surgery 10 minutes.

Manufacturer Narrative

A full analysis of the data logs has been performed and led to the following observations : the user was unable to move the robot arm from the leksell frame pin due to a known software anomaly that can occur when contact is made between an instrument and a surface in cooperative fast mode.The subsequent system shutdown observed most probably results from an excessive force detected in one of the arm joints, but this could not be verified in the controller logs due to a controller malfunction.Upon restart, the user was able to clear the robot arm and to resume the procedure successfully.

Event Description

During bone fiducial registration using leksell frame pins, pointer probe became stuck in position inside the right posterior leksell frame pin.Upon attempt to move from stuck location, emergency shutdown occurred.Patient was anesthetized during this error and successful registration followed power cycle.Delayed surgery 10 minutes.

• 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: 10306883
• MDR Text Key: 200838746
• Report Number: 3009185973-2020-00169
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA ONE
• Device Catalogue Number: ROSAS00203
• Device Lot Number: 3.1.1.1295
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1