MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 209999

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2019

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)(6), (b)(4)- mps reported leaking hydraulic fluid.Case type: no associated procedure.

Manufacturer Narrative

Updated the common device name (d2).Reported event: it was reported that (b)(6) - mps reported leaking hydraulic fluid.Product evaluation and results: as per work order, completed date 2/21/2020: called the mps and had a conversation with him about not leaving the system stored in the lifted/up position- that¿s normal to experience fluid leakage if they do.Product history review: review of the device history records indicate (b)(6) was manufactured and accepted into final stock on 2/17/2012 after being handled.Review of the nprs revealed that the non conformance is unrelated to the failure alleged in this complaint.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209999, (b)(6) shows 0 additional complaints related to the failure in this investigation.Conclusion: per, preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.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 leaking hydraulic fluid.Case type: no associated procedure.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9633917
• MDR Text Key: 176498748
• Report Number: 3005985723-2020-00052
• 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

• Date FDA Received: 01/27/2020
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other