MAUDE Adverse Event Report: MAKO SURGICAL CORP. USB TO FIBER CONVERTERS, LEX; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207798

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

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

Event Date 03/07/2018

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

(b)(6).Update: rob 092.Tka.Noticed during procedure.Patient involvement: system went down between femur cuts.No harm to patient.No adverse consequences to patient.Surgical delay >30 mins.Procedure was completed successfully with manual instrumentation.Approval to use bypass cable was not given in time to finish bone cuts with robot.

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections based on the results of investigation.Mps reported camera connection error.Device evaluation and results: (b)(4) arm status check failed.Found the power led for the usb to fiber converter not illuminated.Reseated power adapter and observed the power led flickering.Successfully replaced usb to fiber lex converter.(b)(4), usb to fiber lex converter, 1 ea.Successfully performed pre-surgery checks.A review of device history records shows that on (b)(6) 2010 1 device was inspected and 1 device was placed on: (b)(4).A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.A review of complaints in catsweb and trackwise related to p/n 207798, shows 1 additional complaints related to the failure in this investigation.These complaints are: (b)(4).Conclusions: system 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

(b)(4): mps hope clark reported camera connection error.Update: (b)(4).Tka.Noticed during procedure.Patient involvement: system went down between femur cuts.No harm to patient.No adverse consequences to patient.Surgical delay greater than 30 mins.Procedure was completed successfully with manual instrumentation.Approval to use bypass cable was not given in time to finish bone cuts with robot.

• Brand Name: USB TO FIBER CONVERTERS, LEX
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7404377
• MDR Text Key: 105165207
• Report Number: 3005985723-2018-00224
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K170581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

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: 207798
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/06/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization