3.0 RIO® ROBOTIC ARM - MICS
Report
- Report Number
- 3005985723-2017-00450
- Event Type
- Malfunction
- Date Received
- September 21, 2017
- Date of Event
- September 12, 2017
- Report Date
- March 7, 2018
- Manufacturer
- MAKO SURGICAL CORP.
- Product Code
- OLO
- PMA / PMN Number
- K170581
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
AFTER CHANGING THE SAW BLADE FROM ANGLED ATTACHMENT TO THE STRAIGHT DURING A MAKO TOTAL KNEE WE HAD A CHECKPOINT ERROR ON SAW BLADE. THE OR TEAM REREGISTERED THE RIO UNSUCCESSFULLY MULTIPLE TIMES, WE THEN CHECKED ARM STATUS AND IT SHOWED ¿STATUS OK.¿ WE THEN CHANGED OUT ¿MICS HAND PIECE¿ AND ATTEMPTED TO REREGISTER A COUPLE TIMES AND IT FAILED. WE WENT TO PRESURGERY CHECKS AND HAD SURGEON PERFORM ANGLE DISCREPANCY TEST. WHEN WE TESTED J6 AND FOR FIRST TIME WE RECEIVED AN INDEX ERROR 24 FOR J6. AT THIS TIME, WE RESET ARM SOFTWARE AND WERE ABLE TO COMPLETE THE TKA SURGERY. THERE WAS A SURGICAL DELAY OF 25-30 MINUTES. THE REPORTS PROVIDED IN THE SHARED DRIVE FOLDER: (B)(6) 2017 SHOWED THE ANGLE DISCREPANCY FAILURE ON (B)(6) 2017. PER GSP CASE (B)(6): COULD NOT DUPLICATE THE J6 INDEX ERROR. VERIFIED ALL PRESURGICAL TESTING HAS PASSING RESULTS. VERIFIED ARM LOGGER JOINT 6 VALUES LOOKED GOOD WHILE TURNING JOINT FROM BUMP STOP TO BUMP STOP. VERIFIED J6 GLASS ENCODER IS CLEAN. MATERIAL ANALYSIS: NOT PERFORMED AS NO MATERIAL FAILURE IS ALLEGED. A REVIEW OF THE DHR ASSOCIATED WITH ROB351 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209999, SERIAL NUMBER (B)(4), SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE ISSUE OCCURRED DURING A CASE AND RESULTED IN A 25-30 MINUTE DELAY. THERE WAS NO FURTHER HARM TO THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. NO ACTION IS REQUIRED AT THIS TIME AS THERE IS NO INDICATION TO SUGGEST A PRODUCT NON-CONFORMITY OR UNANTICIPATED HAZARD.
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.
AFTER CHANGING THE SAW BLADE FROM ANGLED ATTACHMENT TO THE STRAIGHT DURING A MAKO TOTAL KNEE WE HAD A CHECKPOINT ERROR ON SAW BLADE. THE OR TEAM REREGISTERED THE RIO UNSUCCESSFULLY MULTIPLE TIMES, WE THEN CHECKED ARM STATUS AND IT SHOWED ¿STATUS OK.¿ WE THEN CHANGED OUT ¿MICS HAND PIECE¿ AND ATTEMPTED TO REREGISTER A COUPLE TIMES AND IT FAILED. WE WENT TO PRESURGERY CHECKS AND HAD SURGEON PERFORM ANGLE DISCREPANCY TEST. WHEN WE TESTED J6 AND FOR FIRST TIME WE RECEIVED AN INDEX ERROR 24 FOR J6. AT THIS TIME, WE RESET ARM SOFTWARE AND WERE ABLE TO COMPLETE THE TKA SURGERY. THERE WAS A SURGICAL DELAY OF 25-30 MINUTES. LOG FILES ARE UPLOADED TO THE SHARED DRIVE, FILE NAME (B)(6) 2017.
AFTER CHANGING THE SAW BLADE FROM ANGLED ATTACHMENT TO THE STRAIGHT DURING A MAKO TOTAL KNEE WE HAD A CHECKPOINT ERROR ON SAW BLADE. THE OR TEAM REREGISTERED THE RIO UNSUCCESSFULLY MULTIPLE TIMES, WE THEN CHECKED ARM STATUS AND IT SHOWED ¿STATUS OK.¿ WE THEN CHANGED OUT ¿MICS HAND PIECE¿ AND ATTEMPTED TO REREGISTER A COUPLE TIMES AND IT FAILED. WE WENT TO PRESURGERY CHECKS AND HAD SURGEON PERFORM ANGLE DISCREPANCY TEST. WHEN WE TESTED J6 AND FOR FIRST TIME WE RECEIVED AN INDEX ERROR 24 FOR J6. AT THIS TIME, WE RESET ARM SOFTWARE AND WERE ABLE TO COMPLETE THE TKA SURGERY. THERE WAS A SURGICAL DELAY OF 25-30 MINUTES. LOG FILES ARE UPLOADED TO THE SHARED DRIVE, FILE NAME (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662714 | 3.0 RIO® ROBOTIC ARM - MICS | STEREOTAXIC DEVICE, ROBOTICS | OLO | MAKO SURGICAL CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |