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

Model Number	TPL0038
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2016
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
The reported event is related to a procedure that was performed at 'desert regional medical center', california us, on (b)(6) 2016.The procedure was performed successfully with no complications.Furthermore, the report mentioned that the sterile cover for the rbt device from the disposable kit had a hole in it.

• Brand Name: RENAISSANCE SYSTEM
• Common Device Name: STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAZOR ROBOTICS LTD.; pob 3140, 5 shacham st.; north industrial park; caesarea, 30889 00; IS 3088900
• MDR Report Key: 7988361
• Report Number: 3005075696-2018-00027
• Device Sequence Number: 18882730
• Product Code: HAW
• UDI-Device Identifier: 07290109180267
• UDI-Public: 07290109180267
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 10/21/2018

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2016
• Initial Report FDA Received Date: 10/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 94