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 Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2020

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.Device not returned.

Event Description

Mps reported some kind of clear fluid coming out of j3.I asked him to make sure it was not just some surface liquid but he said it was leaking out.Patient was not under anesthesia.

Manufacturer Narrative

Reported event: it was reported that mps reported some kind of clear fluid coming out of j3.I asked him to make sure it was not just some surface liquid but he said it was leaking out.Patient was not under anesthesia.Product evaluation and results: robot appears to have been subjected to liquid dripping from overhead while stored that stained the storage covers.Inspected surfaces and system internals to determine the extent of liquid incursion through storage covers with no internal issues found.See attached word document for pictures and details.Performed scheduled ups battery change and preventive maintenance while onsite.Product history review: a review of device history records shows that rob732 was inspected and accepted into stock on (b)(6) 2018 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 rob732 shows no additional complaints related to the failure in this investigation.Nc/ capa history review: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.Conclusion: 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 not confirmed via inspection.It was due to liquid dripping from overhead while stored that stained the storage covers.Also an additional failure of ups battery change is confirmed.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.

Event Description

Mps reported some kind of clear fluid coming out of j3.I asked him to make sure it was not just some surface liquid but he said it was leaking out.Patient was not under anesthesia.

• 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: 10276216
• MDR Text Key: 198900068
• Report Number: 3005985723-2020-00231
• 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: 09/23/2020

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?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/15/2020
• Supplement Dates Manufacturer Received: 08/31/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other