MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO® CAMERA STAND ASSEMBLY; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 209927

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 02/21/2017

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

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system.The surgeon put in the three screws into the iliac crest and put the array on.I went to adjust the camera to get the array in view and the ¿camera connection error (arm status)¿ showed up again.After doing the required steps, we got the error ¿arm status check failed¿ saying the camera connection was ¿not connected".The surgeon opted to complete the case manually.

Manufacturer Narrative

Reported event: the returned device was confirmed to be a rio® camera stand assembly, catalog #: 209927, lot#: unknown.Camera connection error.Device history: a device history review could not be completed as a lot number was not provided.Device inspection: mps reported that camera connection error occured after moving the camera or the camera stand.Fse was able to confirm this and the internal frame assembly including hybrid cable (orange sleeve) and wiring for the camera and surgeon monitor were replaced.The system was again tested in tha and no camera connection error occured upon moving the stand or camera.All presurgery and safety checks passed system is ready for clinical use.Complaint history: a complaint history review could not be completed as neither a lot number was not provided.Conclusion: mps reported camera connection error when camera or stand were moved.Fse confirmed issue and replaced camera frame assembly and camera and monitor wires.System passed all checks and is ready for clinical use.Further action: none at this time.

Event Description

The surgeon was completing a total hip arthroplasty procedure using the robotic arm interactive orthopedic system.The surgeon put in the three screws into the iliac crest and put the array on.I went to adjust the camera to get the array in view and the "camera connection error (arm status)" showed up again.After doing the required steps, we got the error "arm status check failed" saying the camera connection was "not connected." the surgeon opted to complete the case manually.

• Brand Name: RIO® CAMERA STAND ASSEMBLY
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6356026
• MDR Text Key: 68222430
• Report Number: 3005985723-2017-00095
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

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: 209927
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization