MAUDE Adverse Event Report: MAKO SURGICAL CORP. CAMERA, POLARIS SPECTRA; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207335

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 11/09/2017

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

Mps (b)(6) reported failed presurgery check on accuracy test.Smudge removed on ndi camera and performed kin cal again.Accuracy performed with no issues.Performed all checks and tests.Case type: tka.**update** per the mps, the patient was already under anesthesia when the issue occurred and the surgeon proceeded manually.

Manufacturer Narrative

Reported event: the reported device was confirmed to be a camera - polaris spectra (207335) serial number (b)(4).Device history: not performed as the camera - polaris spectra is an oem product.Device inspection: per (b)(4): mps reported failure during presurgery checks.Fse cleaned smudges off ndi camera and kin called system.All accuracy checks passed and system pass all verification tests.Complaint history: based on the device identification the complaint databases were reviewed from 2011 to present for similar reported events regarding the camera - polaris spectra.There have been no other events for the referenced lot number.Conclusion: system was reported to fail accuracy checks during presurgery.Fse confirmed issue and removed smudge from camera lens as well as calibrated the system.Robot passed all accuracy and verification checks and is ready for clinical use.Further action: none at this time.

Event Description

(b)(4) reported failed presurgery check on accuracy test.Smudge removed on ndi camera and performed kin cal again.Accuracy performed with no issues.Performed all checks and tests.Case type: tka.Update: per the mps, the patient was already under anesthesia when the issue occurred and the surgeon proceeded manually.

• Brand Name: CAMERA, POLARIS SPECTRA
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 7099573
• MDR Text Key: 95738649
• Report Number: 3005985723-2017-00617
• 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: 02/23/2018

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: 207335
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/08/2017
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization