BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM

    MDR report key: 5188197 · Received October 29, 2015

    Report

    Report Number
    3005985723-2015-00225
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    September 14, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: THE REPORTED DEVICE WAS CONFIRMED TO BE A RIO ROBOTIC ARM, P/N 203999, SERIAL NUMBER (B)(4). DEVICE EVALUATION AND RESULTS: ACCORDING TO GSP CASE 124026, THE FSE FOUND THAT THE FUSE ON THE ANSPACH FILTER ASSEMBLY WAS BLOWN AND THAT THE ANSPACH CONTROLLER WAS INOPERATIVE. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE ROB123 WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 12/9/2010. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 203999, LOT NUMBER ROB123 SHOWS NO OTHER COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 203999 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #761. CONCLUSIONS: THE FAILURE WAS CONFIRMED DURING THE FIELD SERVICE. 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.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) . DURING THE CASE, THE RIO WAS DISPLAYING ERROR MESSAGES. THE MAKOPLASTY SPECIALIST CONDUCTED TROUBLESHOOTING ACTIVITIES AND THERE WAS A CASE DELAY OF APPROXIMATELY 15 MINUTES DUE TO THE TROUBLESHOOTING. ANOTHER ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WAS BROUGHT IN TO SUCCESSFULLY FINISH THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    A SURGEON WAS PERFORMING A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) . DURING THE CASE, THE RIO WAS DISPLAYING ERROR MESSAGES. THE MAKOPLASTY SPECIALIST CONDUCTED TROUBLESHOOTING ACTIVITIES AND THERE WAS A CASE DELAY OF APPROXIMATELY 15 MINUTES DUE TO THE TROUBLESHOOTING. ANOTHER ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) WAS BROUGHT IN TO SUCCESSFULLY FINISH THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718506 2.1 RIO ROBOTIC ARM INT. ORTH. SYSTEM STEREOTACTIC DEVICE OLO MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention