MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; STEREOTAXIC DEVICE, ROBOTICS

Model Number 209999

Device Problems Difficult or Delayed Positioning (1157); Unintended Movement (3026)

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

Event Date 02/11/2020

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

Case number: (b)(4) - mps reported arm shaking while in haptics.Case type: tka.Update: "no patient harm 20 min delay.".

Manufacturer Narrative

Reported event: it was reported that case number: (b)(4), (b)(6) - mps (b)(6) reported arm shaking while in haptics.Case type : tka.Update: "no patient harm 20 min delay".Product evaluation and results: adjusted j5 and j6 tension cables, kin called both right and left sides.System investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review: a review of device history records shows that (b)(6) was inspected and accepted into stock on 11/8/2010 and was handled.A review of the data revealed that the non-conformances is not related to the failure alleged in this complaint.Complaint history review: a review of complaints in trackwise related to (b)(6) shows 1 complaint related to the failure in this investigation.The complaint is (b)(4).Conclusions: the failure is confirmed via inspection.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.H3 other text : device not returned.

Event Description

Case number: (b)(4), (b)(6) - mps reported arm shaking while in haptics.Case type : tka.Update: "no patient harm 20 min delay".

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9799334
• MDR Text Key: 182403413
• Report Number: 3005985723-2020-00143
• 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: 07/15/2020

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 Model Number: 209999
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/11/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 06/26/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization