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

Catalog Number 209999

Device Problems Connection Problem (2900); Insufficient Information (3190)

Patient Problems Discomfort (2330); No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2017

Event Type  Injury  

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

(b)(4): rob202 - mps (b)(6) reported robot connection problems - application buttons are greyed out.Fse reseated f17 assy and cables.Tested ethernet bypass successfully.Disconnected and reconnected hybrid cables multiple times and was able to power up and perform presurgery checks with no issues.Case type: tha.Delay of approx 30 min.Update per mps 7/11/17: per mps, "the surgeon decided to close the patient up until the robot was fixed.So it was not completed manually or by the robot.However, the patient did receive her pka the following day successfully".Update per mps 7/18/17: upon seeking further clarification from mps in regard to case type, mps replied "my apologies.This was a pka".

Manufacturer Narrative

Reported event: mps reported robot connection problems - application buttons are greyed out.Device evaluation and results: upon arrival fse could not duplicate the problem.I cleaned all fiber connections.Reseated f17 assy and cables.Tested ethernet bypass successfully.Fse disconnected and reconnected hybrid cables multiple times and was able to power up and perform pre surgery checks with no issues.Device history review: a review of the dhr associated with (b)(4) found quality inspection procedures successfully passed.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, serial number (b)(4) shows no additional complaints related to the failure in this investigation.Conclusions: fse stopped in the following morning with the mps to make sure he was able to complete pre surgery check with no problem.System is 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.

Event Description

Gsp 148761: (b)(4) - mps (b)(4) reported robot connection problems - application buttons are greyed out.Fse reseated f17 assy and cables.Tested ethernet bypass successfully.Disconnected and reconnected hybrid cables multiple times and was able to power up and perform presurgery checks with no issues.Case type: tha.Delay of approx 30 min.Update per mps 7/11/2017: per mps, "the surgeon decided to close the patient up until the robot was fixed.So it was not completed manually or by the robot.However, the patient did receive her pka the following day successfully".Update per mps 7/18/2017: upon seeking further clarification from mps in regard to case type, mps replied "my apologies.This was a pka".

• 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
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6724169
• MDR Text Key: 80397859
• Report Number: 3005985723-2017-00313
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other