MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 01/09/2019

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

Rob305 - mps (b)(4) reported mics failures.Case type: tka.When was issue noticed? prior to surgery.Was there patient involvement? no.Any patient harm? patient had already received bilateral nerve blocks in holding.Any surgical delay? case was rescheduled for (b)(6) 2019.Was the case cancelled? yes - rescheduled.Was procedure completed successfully? no.Was procedure completed manually? no- case was rescheduled.Was the patient under anesthesia at the time of the issue? patient had already received bilateral nerve blocks in holding area.(b)(6).(b)(4).Description of event: mps called after going through 4 mics that failed mics status check.Troubleshooting steps taken: confirmed mps did a shut down between each mics, which he did.Also confirmed no visual indicators of failure for any of the mics.Brought in local fse to discuss, and mics still could not pass.Error stated fault_mics_server.Disposition of call: not able to proceed, has 4 cases today and tomorrow.Fse escalation required: yes.Resolution: issue: warning came up on monitors reading mics push to hard."sergeon" refused to proceed with robotic assist because of an issue with the monitors going black the previous day.Resolution: monitors black on the previous day because of a bad fiberoptic connection from dirty fibers.The mics issue was unrepeatable and after 7 successful rio registrations with two "diffrent" site owned mics with shut downs and full pre surgeries inbetween the mps and mps manager agreed this was set up related are customer error.Following cases had no issue.System is clear for clinical use.

Manufacturer Narrative

Reported event: it was reported that the mics was non functional resulting in the rescheduling of the case , patient had already received bilateral nerve blocks in holding.Product evaluation and results: the product was not evaluated as the product was unavailable for inspection.Product history review: product history review was not performed as the lot and serial number of the device was not provided.Complaint history review: complaint history review was not performed as the lot and serial number of the device was not provided.Conclusions: the failure could not be determined as the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been an nc and capa associated with the product and failure mode reported in this event.This is (b)(4) and capa 1450904.Product was not available for evaluation.

Event Description

Rob305 - mps (b)(6) reported mics failures.Case type; tka.When was issue noticed? prior to surgery.Was there patient involvement? no.Any patient harm? patient had already received bilateral nerve blocks in holding.Any surgical delay? case was rescheduled for (b)(6) 2019.Was the case cancelled? yes.Rescheduled.Was procedure completed successfully? no.Was procedure completed manually? no.Case was rescheduled.Was the patient under anesthesia at the time of the issue? patient had already received bilateral nerve blocks in holding area.Site: (b)(6) medical center.City, state: (b)(6).Robot number: rob305.Mps name: (b)(6).Mps number: (b)(6).Description of event:mps called after going through 4 mics that failed mics status check.Troubleshooting steps taken: confirmed mps did a shut down between each mics, which he did.Also confirmed no visual indicators of failure for any of the mics.Brought in local fse to discuss, and mics still could not pass.Error stated fault_mics_server disposition of call:not able to proceed, has 4 cases today and tomorrow.Fse escalation required: yes.Resolution: issue: warning came up on monitors reading mics push to hard.Surgeon refused to proceed with robotic assist because of an issue with the monitors going black the previous day.Resolution: monitors black on the previous day because of a bad fiberoptic connection from dirty fibers.The mics issue was unrepeatable and after 7 successful rio registrations with two different site owned mics with shut downs and full pre surgeries inbetween the mps and mps manager agreed this was set up related are customer error.Following cases had no issue system is clear for clinical use.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8288977
• MDR Text Key: 134523845
• Report Number: 3005985723-2019-00086
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030193
• UDI-Public: 00848486030193
• Combination Product (y/n): N
• PMA/PMN Number: K142530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 209063
• Device Lot Number: NOT REPORTED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 84