MAUDE Adverse Event Report: MAKO SURGICAL CORP. CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209954

Device Problems Electrical /Electronic Property Problem (1198); Insufficient Information (3190)

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

Event Date 03/19/2018

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

No response when trigger engaged to initiate rio setup.We had no response from any of the mics tried during the case; the doctor decided to complete surgery without robotic assistance.Tha case delayed 10 minutes.

Event Description

No response when trigger engaged to initiate rio setup.We had no response from any of the mics tried during the case; the doctor decided to complete surgery without robotic assistance.Tha case delayed 10 minutes.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.The mps reported that the mics stopped working and none of the mics will pass mics testing during tha case.Device inspection: per gsp (b)(4).Mps reported that the mics stopped working and none of the mics will pass the mics testing during tha.Tested a known working mics hand piece with a failing result.Replaced cutter power input delivery assembly (b)(4).Tested all of the hospital's 5 mics hand pieces with passing results.System successfully passed all system checks and tests.System is ready for clinical use.A review of the dhr associated with (b)(4) found qips passed with no notes or comments.A review of complaints in catsweb and trackwise related to the cutter power input delivery assembly 3.0, catalog #: 209954, robot #: (b)(4) shows 1 additional complaint related to the failure in this investigation.The complaint is: (b)(4).Per fse: the cutter power input delivery assembly 3.0 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.

• Brand Name: CUTTER POWER INPUT DELIVERY ASSEMBLY 3.0
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7442264
• MDR Text Key: 106033352
• Report Number: 3005985723-2018-00247
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

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: 209954
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/30/2018
• Supplement Dates FDA Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization