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

Catalog Number 207335

Device Problem Output Problem (3005)

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

Event Date 06/11/2019

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

Case number: (b)(4), mps (b)(6) called to report fault light illuminated on camera during case.When light came on, camera could no longer recognize any arrays or see anything.Case type: rtka.Surgery was not completed robotically.Update: "~30 mins' surgical delay.Case was not cancelled, , "went manual".

Event Description

Case number: (b)(4), mps (b)(6) called to report fault light illuminated on camera during case.When light came on, camera could no longer recognize any arrays or see anything.Case type: rtka.Surgery was not completed robotically.Update: "~30 mins' surgical delay.Case was not cancelled, , "went manual".

Manufacturer Narrative

Reported event: mps (b)(6) called to report fault light illuminated on camera during case.Device evaluation and results: per (b)(4): fse replaced the camera.System was found to be within mako tolerances and specifications.Product history review: a review of device history records shows that on 08/03/18 1 device was inspected and 1 device was placed on: qt18-07-0099, qt18-08-0002.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review : a review of complaints in catsweb and trackwise related to p/n 207335 shows no additional complaints related to the failure in this investigation.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.

• 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: 8736872
• MDR Text Key: 149267031
• Report Number: 3005985723-2019-00471
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• 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: 09/04/2019

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: 207335
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization