MAUDE Adverse Event Report: MAKO SURGICAL CORP. POWER CORD, TGS SYSTEM V2, 20' LG; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number 207010

Device Problems Sparking (2595); Electrical Power Problem (2925)

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

Event Date 02/05/2020

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

Power cord sparking.High volume account.Please send replacement asap.Overnight if possible.Thanks! case type: tka.

Manufacturer Narrative

Reported event: the device, power cord, tgs system v2, 20' lg, catalog #207010, was reported to spark and smoke.Device inspection: no device inspection could be completed as the product was not available for evaluation.Device history review: a review of device history records shows that on 02/11/2016 1 device was inspected and 1 device was placed on: qt 16-01-0068 and 16-01-0073.A review of the data revealed that the non-conformances are not related to the failure alleged in this compliant.Complaint history: a review of complaints in catsweb and trackwise related to power cord, tgs system v2, 20' lg, catalog #: 207010 shows no additional complaints related to the failure in this investigation.Conclusions: per d03391, 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.No additional investigation or specific actions are required.Further action: none at this time.

Event Description

Power cord sparking.High volume account.Please send replacement asap.Overnight if possible.Thanks! case type: tka.

• Brand Name: POWER CORD, TGS SYSTEM V2, 20' LG
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9772622
• MDR Text Key: 183328885
• Report Number: 3005985723-2020-00123
• 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: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 207010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other