MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® GUIDANCE MODULE; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	207110
Medical Device Problem Codes	Computer Software Problem (1112); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Frozen display in gud monitor and surgeon monitor during mako tka and tha procedures.There was a delay in surgery because of the freezing."the length of surgical delay could be noted as more than half an hour in this case".
Event or Problem Description
Frozen display in gud monitor and surgeon monitor during mako tka and tha procedures there was a delay in surgery because of the freezing."the length of surgical delay could be noted as more than half an hour in this case".
Additional Manufacturer Narrative
Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: frozen display in gud monitor and surgeon monitor during mako tka and tha procedures.Device evaluation and results: per wo-(b)(4): replaced the network cable between the cpida and cpci assy and tested the mics unit is fine.Product history review a review of device history records shows that on 01/31/17 1 device was inspected and 1 device was placed on: qt 17-01-0087, qt 17-01-0104, qt 17-01-0095, qt 17-01-0096.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 207110, 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: RIO® GUIDANCE MODULE
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8617649
• Report Number: 3005985723-2019-00365
• Device Sequence Number: 296383
• Product Code: OLO
• UDI-Device Identifier: 00848486022211
• UDI-Public: 00848486022211
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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 Catalogue Number: 207110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 08/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization