MAUDE Adverse Event Report: MAZOR ROBOTICS LTD. RENAISSANCE SYSTEM; STEREOTAXIC INSTRUMENT

Model Number	TPL0038
Medical Device Problem Codes	Mechanics Altered (2984); Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This adverse event is being submitted shortly after the company completed an internal retrospective review process of historic records.
Event or Problem Description
During a brain surgery with the renaissance system on (b)(6) 2014 at (b)(6), there was a movement of the upper part of the renaissance rbt device (i.E., (b)(4) carousel).The case was planned as a deep brain stimulation procedure with bilateral trajectories (left and right sub thalamic nucleus) for motion disorders / parkinson's disease.The product was mounted to the patient in accordance with the renaissance surgical technique.Three cannulas and electrodes (third party manufacturer) were inserted into the patient's brain.While the product was mounted to the patient and in a locked position, there was a movement - a rotational shift in the rbt carousel.The carousel is a rotational platform.It has 18 discrete stations, and there is a pin pressed by a spring that locks the platform in station.The issue was malfunctioning of the mechanism that locks the carousel in a specific station.

• Brand Name: RENAISSANCE SYSTEM
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3104, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• MDR Report Key: 8001805
• Report Number: 3005075696-2018-00029
• Device Sequence Number: 1531307
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K120812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TPL0038
• Device Catalogue Number: TPL0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2016
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 59