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 03/23/2020

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

Mps reported leaking hydraulic fluid.Case type : not reported.

Manufacturer Narrative

Update to b2 and d2.Reported event: it was reported that ¿case number: (b)(4), rob084 - mps reported leaking hydraulic fluid.Case type : not reported¿.Product evaluation and results: the field service engineer reported: problem reproduced? yes.Trouble shooting notes: none.Work performed: -verified lift fluid leaking; -reservoir had too much fluid; -removed fluid to proper levels; -performed system check.Work order disposition: 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 rob084 was inspected on 25/01/2010 and was handled via npr.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 catsweb and trackwise related to p/n 209999, shows no additional complaints related to the failure in this investigation.Conclusions: (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 was confirmed and reproduced.System is ready for clinical use.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Mps reported leaking hydraulic fluid.Case type : not reported.

• 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: 9957874
• MDR Text Key: 187587427
• Report Number: 3005985723-2020-00195
• 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: 03/23/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/23/2020
• 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; Other