MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209999

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

(b)(4) - mps (b)(6) reported auto-failure of rio verification during tka case.Case number: (b)(4).Case type: tka.Update: "approx.90 minute surgery delay resulting in cancellation.".

Event Description

(b)(6) - mps (b)(6) reported auto-failure of rio verification during tka case.Case number: (b)(4).Case type: tka.Update: "approx.90 minute surgery delay resulting in cancellation.".

Manufacturer Narrative

Reported event: "(b)(6) - mps (b)(6) reported auto-failure of rio verification during tka case.Case number: (b)(4).Case type: tka.Update: ""approx.90 minute.Surgery delay resulting in cancellation." device evaluation and results: wo-(b)(4): auto arm accuracy failed during presurgery on right side.Performed kin cal on right side.Product history review: a review of device history records shows that on 03/02/17 1 device was inspected and 1 device was placed on: qt 17-02-0073.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(6) shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9235764
• MDR Text Key: 178351648
• Report Number: 3005985723-2019-00757
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2020

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
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization