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

Catalog Number 211123

Device Problems Application Program Problem: Parameter Calculation Error (1449); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2019

Event Type  malfunction  

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

Robot failed verification on right hand side prior to case.Surgeon then performed an auto arm accuracy test on rhs and it failed.In previous pm check, technician had re-calibrated arm accuracy on lhs and rhs.Suspected robot cpci unit did not permanently save calibration parameters, causing accuracy failures over time.Surgical delay.Unable to perform surgery until robot had been repaired by technician.Update: "was patient in the operating room at the time of discovery? yes.Was patient under anesthesia? yes.Was surgical procedure completed successfully (yes/ no/ no associated procedure)? procedure completed using navigation.Please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay): 20 minutes, tka.Completed manually.".

Manufacturer Narrative

Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.6, h.10 and h.11 based on the results of investigation.Mps reported pre-surgery accuracy failure.Device inspection: no device inspection could be completed as the product was not available for evaluation.Device history review: a review of the dhr associated with rob526 found qips passed with no notes or comments.Complaint history: a review of complaints in catsweb and trackwise related to the cpci motion control assembly 3.0 rohs, catalog #: 211123 shows no additional complaints related to the failure in this investigation.Conclusion: the reported issue could not be evaluated as the device was not available.

Event Description

Robot failed verification on right hand side prior to case.Surgeon then performed an auto arm accuracy test on rhs and it failed.In previous pm check, technician had re-calibrated arm accuracy on lhs and rhs.Suspected robot cpci unit did not permanently save calibration parameters, causing accuracy failures over time.Surgical delay.Unable to perform surgery until robot had been repaired by technician.Update: "was patient in the o.R.At the time of discovery? yes.Was patient under anesthesia? yes · was surgical procedure completed successfully (yes/ no/ no associated procedure)? procedure completed using navigation · please estimate any surgical delay, even if under a minute (or indicate ¿none¿ to confirm there was absolutely no delay): 20 minutes, tka.Completed manually".

• 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
• MDR Report Key: 8946470
• MDR Text Key: 156177560
• Report Number: 3005985723-2019-00609
• Device Sequence Number: 1
• Product Code: OLO
• 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: 11/25/2019

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: 460123-2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/18/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 87 YR