3.0 RIO® ROBOTIC ARM - MICS
Report
- Report Number
- 3005985723-2019-00574
- Event Type
- Malfunction
- Date Received
- August 7, 2019
- Date of Event
- August 6, 2019
- Report Date
- October 21, 2019
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- OLO
- UDI-DI
- 00848486030407
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
FOLLOW-UP #1 AND FINAL REPORT SUBMITTED. REPORTED EVENT: WHEN GETTING READY TO MAKE CUTS RECEIVED THE ERROR THAT THE ROBOTIC ARM WAS PUSHED TO HARD. COULD NOT CLEAR ERROR. CALLED CLINICAL SUPPORT. TRIED RESTART ARM SOFTWARE. DIDN¿T CLEAR ERROR. WENT TO ARM STATUS CHECK AND HAD A MOTOR ERROR IN RED. TRIED A HARD SHUT DOWN. WHEN GOING TO HOME THE ROBOT RECEIVED ERROR MESSAGE UNABLE TO CONNECT TO ROBOT. CRISIS RETURNED ERROR:INTER-PROCESS COMMUNICATION ERROR IN ARM SOFTWARE. WENT TO USE BACKUP ETHERNET PORT. STILL RECEIVED UNABLE TO CONNECT ERROR. ABORTED ROBOTICS CASE AND WENT MANUAL. DEVICE EVALUATION AND RESULTS: PER (B)(4): WAS NOT ABLE TO REPRODUCE PROBLEM. PROACTIVELY REPLACED POWER ISOLATION STATION AND UPS ASSEMBLY, TO ISOLATE ANY POTENTIAL ISSUES ON ROBOT SIDE. SYSTEM INVESTIGATION COMPLETED SUCCESSFULLY AS PER SERVICE MANUAL. ALL SYSTEM CHECKS AND TESTS PASSED. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 11/23/2011 1 DEVICE WAS INSPECTED AND 1 DEVICE WAS PLACED ON: NPR 11-11-0019, NPR 11-11-0009, NPR 11-11-0021, NPR 11-11-0021, NPR 11-11-0040, NPR 11-11-0051, NPR 11-10-086, NPR 11-08-0127, NPR 11-09-0016, NPR 11-09-0018. 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: 209999 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.
WHEN GETTING READY TO MAKE CUTS RECEIVED THE ERROR THAT THE ROBOTIC ARM WAS PUSHED TO HARD. COULD NOT CLEAR ERROR. CALLED CLINICAL SUPPORT. TRIED RESTART ARM SOFTWARE. DIDN¿T CLEAR ERROR. WENT TO ARM STATUS CHECK AND HAD A MOTOR ERROR IN RED. TRIED A HARD SHUT DOWN. WHEN GOING TO HOME THE ROBOT RECEIVED ERROR MESSAGE UNABLE TO CONNECT TO ROBOT. CRISIS RETURNED ERROR:INTER-PROCESS COMMUNICATION ERROR IN ARM SOFTWARE. WENT TO USE BACKUP ETHERNET PORT. STILL RECEIVED UNABLE TO CONNECT ERROR. ABORTED ROBOTICS CASE AND WENT MANUAL. CASE TYPE: TKA. SURGICAL DELAY 16-30 MINUTES. SURGERY NOT COMPLETED ROBOTICALLY.
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.
WHEN GETTING READY TO MAKE CUTS RECEIVED THE ERROR THAT THE ROBOTIC ARM WAS PUSHED TO HARD. COULD NOT CLEAR ERROR. CALLED CLINICAL SUPPORT. TRIED RESTART ARM SOFTWARE. DIDN¿T CLEAR ERROR. WENT TO ARM STATUS CHECK AND HAD A MOTOR ERROR IN RED. TRIED A HARD SHUT DOWN. WHEN GOING TO HOME THE ROBOT RECEIVED ERROR MESSAGE UNABLE TO CONNECT TO ROBOT. CRISIS RETURNED ERROR: INTER-PROCESS COMMUNICATION ERROR IN ARM SOFTWARE. WENT TO USE BACKUP ETHERNET PORT. STILL RECEIVED UNABLE TO CONNECT ERROR. ABORTED ROBOTICS CASE AND WENT MANUAL. CASE TYPE: TKA. SURGICAL DELAY 16-30 MINUTES. SURGERY NOT COMPLETED ROBOTICALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664312 | 3.0 RIO® ROBOTIC ARM - MICS | STEREOTAXIC DEVICE, ROBOTICS | OLO | MAKO SURGICAL CORP. | 00848486030407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization |