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

Model Number ROSA 2.5.8

Device Problem Unintended Arm Motion (1033)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

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

It was reported that the robot drifted to the right side (instrument moved left) although surgeon wanted to go deeper in the brain.

Manufacturer Narrative

It was reported that during a surgery, the endoscope drifted instead of going deeper in the brain.According to the results of the technical investigation, the event was caused by a contact with the skull edge which caused a request of motion and the drift.Corrected data: date of this report, if follow-up, what type, device evaluated by manufacturer, evaluation code, date received by manufacturer.

Manufacturer Narrative

The endoscope was or entered probably in contact with the skull edge, during free cooperative movements.The efforts measured by the force sensor has been interpreted by the system as a request of motion explaining the sensation of drift.It is normal behavior of the device.The ifu "rosa-041-2.5.8-c-en manuel d'utilisation rosa english" contains a warning that says: "do not use the fast speed when the endoscope is inserted into the patient head.The slow speed is more adapted for manipulating the endoscope inside the brain." during the drift, the surgeon was is medium speed, this is not the more adapted speed for an endoscopy.Plus, during an endoscopy, when the speed is not slow speed a message appears to warn the user that he has to be careful.The root cause of the event is usage of the free medium cooperative mode in endoscopy by the user.

• 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; 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: 7227359
• MDR Text Key: 98973747
• Report Number: 3009185973-2018-00041
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK101791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2018
• 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: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2011
• 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