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

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.

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.

Manufacturer Narrative

Reported event: an event regarding a incorrect patient data and user error involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported, robot serial #: unknown.It was 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 had not taken the time to review the pre plan properly before putting the pins in the pelvis.Method & results: product evaluation and results: not performed as case session data was not provided.Product history review: a review of the device history records could not be performed as the robot serial number was not reported.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for tha software - incorrect patient data.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tha software - incorrect patient data h3 other text : device not returned.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8478332
• MDR Text Key: 140775917
• Report Number: 3005985723-2019-00272
• 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: health professional
• 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 Received: 04/03/2019
• 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
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR