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

Model Number 209999

Device Problem Application Program Problem: Parameter Calculation Error (1449)

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

Event Date 12/06/2019

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 (b)(6) reported arm shaking when moving into haptics, power glitches, and inaccurate cuts.Case type: not reported.

Manufacturer Narrative

Updated b2."reported event: case number: (b)(4) - mps reported arm shaking when moving into haptics, power glitches, and inaccurate cuts.Device evaluation and results: as per the work order completed on (b)(6)2019 adjusted j2 bump stops to recommended stopping positions.Replaced the lower trunk shock.Verified all transmission cables are at recommended tensions.System investigation completed successfully as per service manual.All system checks and tests passed, system is ready for use.Product history review review of the device history records indicate (b)(4) devices was manufactured, handled and accepted into final stock on (b)(6)2015.A review revealed that that the non-conformance is not related to the failure alleged in this compliant.Complaint history review a review of complaints in catsweb and trackwise related to p/n 209999, lot number rob339 shows no additional complaints related to the failure in this investigation.Conclusions: the failure was confirmed as alleged 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) - mps reported arm shaking when moving into haptics, power glitches, and inaccurate cuts.Case type: not reported.

• 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: 9530777
• MDR Text Key: 191919817
• Report Number: 3005985723-2019-00926
• 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: 05/14/2020

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: 12/06/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 05/11/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other