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

Catalog Number 209999

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

As part of 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

Gsp 164319: mps (b)(6) reported sparking at outlet.

Manufacturer Narrative

Report event: sparking was reported at the outlet.Device inspection: per gsp case #: 164319 mps dylan smith reported sparking at outlet.- power cord was replaced and problem was resolved.- system successfully passed all validation testing.- verified system is operating within mako tolerances and specifications.- system is ready for clinical use.Device history review: a review of the dhr associated with rob118 found qips passed with no notes or comments.Complaint history: a review of complaints in catsweb and trackwise related to the power cord, tgs system v2, 20' lg, catalog #: 207010, robot #: rob118 shows no additional complaints related to the failure in this investigation.Conclusion: per fse: the power cord was replaced.The system successfully passed all validation testing and is operating within mako tolerances and specifications.The system is ready for clinical use.Further action: none at this time.

Event Description

Gsp 164319: mps dylan smith reported sparking at outlet.

• 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: 7302553
• MDR Text Key: 101144334
• Report Number: 3005985723-2018-00094
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization