MAUDE Adverse Event Report: MAKO SURGICAL CORP. COMPUTER, SS2U PROGRAMMED; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 210641

Device Problems Computer Software Problem (1112); Output Problem (3005)

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

Event Date 04/29/2019

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

Frozen display in gud monitor and surgeon monitor during mako tka and tha procedures.There was a delay in surgery because of the freezing."the length of surgical delay could be noted as more than half an hour in this case".

Manufacturer Narrative

Follow-up #1 and final report submitted.Reported event: frozen display in gud monitor and surgeon monitor during mako tka and tha procedures.Device evaluation and results: per (b)(4): replaced the network cable between the cpida and cpci assy and tested the mics unit is fine.Product history review: a review of device history records shows that on 01/31/2017 1 device was inspected and 1 device was placed on: qt 17-01-0087, qt 17-01-0104, qt 17-01-0095, qt 17-01-0096.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 210641 shows no additional complaints related to the failure in this investigation.Conclusions: system ready for clinical use.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

Frozen display in gud monitor and surgeon monitor during mako tka and tha procedures.There was a delay in surgery because of the freezing."the length of surgical delay could be noted as more than half an hour in this case".

• Brand Name: COMPUTER, SS2U PROGRAMMED
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8603072
• MDR Text Key: 144824635
• Report Number: 3005985723-2019-00360
• Device Sequence Number: 1
• Product Code: OLO
• 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: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210641
• Device Lot Number: 490641-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization