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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS

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MAKO SURGICAL CORP. 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 209999
Device Problems Use of Device Problem (1670); Patient Data Problem (3197)
Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  Injury  
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
Sales rep reported that the surgical plan was planned for the wrong operative side. After putting the pins in the patient, this issue was noticed and the surgeon completed the case manually. The rep mentioned that the surgeon hadn¿t taken the time to review the pre plan properly before putting the pins in the pelvis. Hence the delayed time to catch the issue. Surgical delay < 5 minutes. Case was completed manually. Additional information received from rep: patient time out. Realised wrong plan was loaded, due to patient name and noticed the two plans for the day had each plan been labelled for the wrong surgeon. (i was covering for a colleague. ) when correct plan was opened the ct info was used to verify patient on table and then surgeon was keen to proceed with his pins without reviewing the plan even after i requested. Following femoral neck cut before bone registration we notice landmarks were reversed due to the wrong side and we abandoned and went to manual. Surgeon was happy to continue manually and with his final result, using the pre plan as a visual guide for implant sizing. Pelvic pins inserted in stab incision of the illiac crest. Small impaction check point placed in greater trochanter was inserted (standard procedure for robotic hips). Case was then completed manually rendering the pelvic pins/check point unnecessary.
 
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Brand Name3.0 RIO® ROBOTIC ARM - MICS
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key8478332
MDR Text Key140775917
Report Number3005985723-2019-00272
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number209999
Device Catalogue Number209999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/03/2019 Patient Sequence Number: 1
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