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

Catalog Number 209999

Device Problems Electrical /Electronic Property Problem (1198); Electrical Power Problem (2925)

Patient Problem Shock (2072)

Event Date 03/26/2019

Event Type  Injury  

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

Moved robot from room 1 to room 2 after first case.Went and did standard arm status and homed robotic arm.Pulled robot away from center of room to make way for staff.As i was walking back to gud robot started to beep.Immediately checked power cord in back of robot with no issue.Ran back over to do arm status check and had ups main power failure.Went to disconnect plug from wall outlet and went to different outlet.In the interim i called customer service and they gave me troubleshooting to fix the ups power error.As i plugged in robot i was shocked and sparks shot from wall outlet.Immediately unplugged robot and called back customer service and explained situation.Was advised to cancel remaining cases and advised fse would be coming to diagnose robot issue.Case type: all.

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: mps reported ups main power failure error and sparks/crackling in power cord once plugged in.Device inspection: per service max #: wo-01583318: fse noted: successfully replaced power cord.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 rob199 found qips passed with no notes or comments.Complaint history: a review of complaints in catsweb and trackwise related to 3.0 rio® robotic arm - mics, catalog #: 209999 shows no additional complaints related to the failure in this investigation.Conclusion: the robot power cord was replaced.After replacement, the system passed all status checks and is ready for clinical use.Further action: none at this time.

Event Description

Moved robot from room 1 to room 2 after first case.Went and did standard arm status and homed robotic arm.Pulled robot away from center of room to make way for staff.As i was walking back to gud robot started to beep.Immediately checked power cord in back of robot with no issue.Ran back over to do arm status check and had ups main power failure.Went to disconnect plug from wall outlet and went to different outlet.In the interm i called customer service and they gave me troubleshooting to fix the ups power error.As i plugged in robot i was shocked and sparks shot from wall outlet.Immediately unplugged robot and called back customer service and explained situation.Was advised to cancel remaining cases and advised fse would be coming to diagnose robot issue.Case type: all.

• 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: 8515207
• MDR Text Key: 141964823
• Report Number: 3005985723-2019-00296
• 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: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization