MAUDE Adverse Event Report: MAKO SURGICAL CORP. CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 211123

Device Problems Electrical /Electronic Property Problem (1198); Communication or Transmission Problem (2896)

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

Event Date 07/05/2017

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

(b)(4) - mps (b)(6) reported system will not communicate, incompatible robot system error.Fse found crisis would not start, not allowing rio to communicate.Cpci requires replacement.Successfully replaced cpci.Case type: pka.Update per mps 7/17/2017.Case cancelled.Unable to complete mako uni because robot to communicate with guidance system issue.

Manufacturer Narrative

Reported event: the device cpci motion control assembly 3.0 rohs, catalog # 211123, lot/serial no.(b)(4), rma # (b)(4), (b)(4).Unable to complete mako pka because robot communication with guidance system issue.Case cancelled.Device inspection: per gsp case #: (b)(4), fse noted: successfully replaced cpci.Cpci removed pn 211123-r, lot (b)(4), returned on rma# (b)(4).System successfully passed all validation testing.Verified system is operating within mako tolerances and specifications.Attached all supporting documentation.System is ready for clinical use.Device history review: a review of the dhr associated with (b)(4) found qips passed with no notes or comments.Complaint history: based on the device identification, the trackwise complaint databases were reviewed from 2016 to present for similar reported events regarding the cpci motion control assembly 3.0 rohs, catalog #: 211123, lot/serial no.: (b)(4).There have been no other similar events for the referenced serial number.A review of cases in gsp related to (b)(4) shows one additional complaint related to the failure in this investigation.This complaint is: pr (b)(4).Conclusion: per fse: changed suspect cpci motion control assembly 3.0 rohs, catalog # 211123 and the system successfully passed all validation testing.The system is ready for clinical use.Further action: none at this time.

Event Description

(b)(4): mps (b)(6) reported system will not communicate, incompatible robot system error.Fse found crisis would not start, not allowing rio to communicate.Cpci requires replacement.Successfully replaced cpci.Case type: pka.Update per mps 7/17/2017: case cancelled.Unable to complete mako uni because robot to communicate with guidance system issue.

• Brand Name: CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS
• 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: 6733915
• MDR Text Key: 80769687
• Report Number: 3005985723-2017-00332
• 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: 09/25/2017

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: 211123
• Device Lot Number: 21112332-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/29/2017
• Supplement Dates FDA Received: 09/25/2017
• 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): Hospitalization