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

Model Number ROSA 2.5.8

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not been evaluated yet for investigation purpose.Once the evaluation will be performed, a follow-up medwatch report will be submitted. .

Event Description

During the dbs case on (b)(6) 2018 (b)(6) stated to field service engineer, that they had a message displayed by the device that the robot would not move to trajectory with one of the microdrive holders during the surgery on (b)(6) 2018 (mt-02-078 s12001).With the second microdrive holder the robot moved to trajectory successfully (mt-02-078 s15002).On (b)(6) 2018 case, the microdrive holder which was taken from sterile tray to perform this surgery was the one which was working on (b)(6) 2018 surgery (mt-02-078 s15002).Surgeon tried to send the robot on trajectory with the other microdrive holders for testing purposes and found that it still didn't not work (mt-02-078 s12001).There was a delay of 1-2 minutes.No patient consequences were reported.Field service engineer looked into the log-files and mt-02-078 s15002 was ok.Mt-02-078 s12001 the robot was not possible to go on trajectory.

Manufacturer Narrative

It was reported that during the verification of the trajectories accessibility, the robot displayed the message "the robot would not move to trajectory¿ with one of the microdrive holders.A dhr review and a complaint history review were performed and did not identify any contributory factors to the event.A thorough analysis of data logs indicates that this is a normal behavior of the device during the verification of the trajectories accessibility.Indeed, microdrive holders exhibit different characteristics and for each one the robot determines if the subject trajectory is accessible.Therefore there is no device failure.

• Brand Name: ROSA SURGICAL DEVICE
• 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: 7761304
• MDR Text Key: 116394463
• Report Number: 3009185973-2018-00218
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROSA 2.5.8
• Device Catalogue Number: ROSA
• Device Lot Number: 2.5.8.4
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1