MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO SYSTEM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number MAKO

Device Problem Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

The mako robot for doctor was malfunctioning as the patient was intubated, but not prepped or draped.The patient was safely woken up and brought back the same day.Doctor met with patient and family.All supplies were not used and were properly returned.

• Brand Name: MAKO SYSTEM
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• MDR Report Key: 16761383
• MDR Text Key: 313512994
• Report Number: 16761383
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2023

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 Model Number: MAKO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1