MAUDE Adverse Event Report: MAKO SURGICAL CORP. ANSPACH EMAX 2 PLUS BURR MOTOR; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 110940

Device Problems Electrical /Electronic Property Problem (1198); Non Reproducible Results (4029)

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

Event Date 12/26/2017

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 no response from anspach motor.It would not turn on.Fse could not duplicate the problem.Subsequently, completed pm service.Verified system is operating within mako tolerances and specifications.Update: rio 095; pka.Issue was noticed in the middle of the case.No direct patient involvement although they were impacted because it caused about a 45-60 min delay.When the burr did not work for the burring, foot pedal control was attempted but did not work.Tried a new anspach and still did not work.Then tried a new foot pedal which also did not work.Tried shutting down the robot and burr override still did not work.We had to swap robots in the middle of the case and started over.After speaking with (b)(6) we believe using the burr override function produced an error that did not fix when the robot was fully shut down but by the time he case to duplicate and fix the error it had fixed itself.Resolution is to stop using burr override going forward.Case was completed successfully with a different robot (not manually).

Event Description

(b)(4) - mps (b)() reported no response from anspach motor.It would not turn on.Fse could not duplicate the problem.Subsequently, completed pm service.Verified system is operating within mako tolerances and specifications.Update: rio 095 pka issue was noticed in the middle of the case.No direct patient involvement although they were impacted because it caused about a 45-60 min delay.When the burr did not work for the burring, foot pedal control was attempted but did not work.Tried a new anspach and still did not work.Then tried a new foot pedal which also did not work.Tried shutting down the robot and burr override still did not work.We had to swap robots in the middle of the case and started over.After speaking with (b)() we believe using the burr override function produced an error that did not fix when the robot was fully shut down but by the time he case to duplicate and fix the error it had fixed itself.Resolution is to stop using burr override going forward.Case was completed successfully with a different robot (not manually).

Manufacturer Narrative

Reported event: anspach emax 2 plus burr motor would not turn on.Method & results: device evaluation and results: device evaluation was performed and the anspach emax 2 plus burr motor event was not confirmed per gsp case.Device history review: not performed as the anspach emax 2 plus burr motor is an oem product.Complaint history review: based on the device identification, the catsweb and trackwise complaint databases were reviewed from 2011 to present for similar reported events regarding anspach emax 2 plus burr motor would not turn on failure of p/n: 110940, s/n: (b)(4).There have been no other similar events for the referenced serial number.Conclusions: the anspach emax 2 plus burr motor is an oem device.The anspach emax 2 plus burr motor reported event was not confirmed per gsp case.Corrective action/preventive action: as the event did not involve a manufacturing related product problem indicating a non-conformity, adverse trend, or unanticipated hazard, no corrective action is required at this time.

• Brand Name: ANSPACH EMAX 2 PLUS BURR MOTOR
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7504432
• MDR Text Key: 108366236
• Report Number: 3005985723-2018-00287
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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: 110940
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 07/19/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization