BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS

    MDR report key: 7201972 · Received January 17, 2018

    Report

    Report Number
    3005985723-2018-00025
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    September 20, 2017
    Report Date
    February 21, 2018
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    PMA / PMN Number
    K170584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    "REPORTED EVENT: (B)(4) WAS SHOWING CONNECTION ERROR NOT FIXABLE BY THE BYPASS CABLE. DEVICE EVALUATION AND RESULTS: PER FSR 0339: REPLACED CPCI ASSEMBLY. PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 09/24/2009 1 DEVICE WAS/WERE INSPECTED AND 1 DEVICE WAS/WERE PLACED ON NC/NPR/QT: (B)(4), REVEALED THAT THE NON-CONFORMANCE IS/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 211123, (B)(4) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PERFORMED ALL THE REQUIRED TESTS; TESTS PASSED WITH SUCCESS. 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 · 0

    A SURGEON WAS PERFORMING A MAKOPLASTY PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, CONNECTION ERROR NOT FIXABLE BY THE BYPASS CABLE OCCURRED CAUSING A DELAY >30 MINS. ANOTHER ROBOT HAD TO BE BROUGHT INTO THE ROOM TO COMPLETE THE CASE. THIS DID NOT NEGATIVELY IMPACT THE CASE, THE OUTCOME WAS SUCCESSFUL, AND THERE WAS NO HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT: (B)(4) WAS SHOWING CONNECTION ERROR NOT FIXABLE BY THE BYPASS CABLE. DEVICE EVALUATION AND RESULTS: PER (B)(4): REPLACED CPCI ASSEMBLY. PRODUCT HISTORY REVIEW A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT ON 09/24/2009 1 DEVICE WAS/WERE INSPECTED AND 1 DEVICE WAS/WERE PLACED ON NC/NPR/QT: (B)(4), REVEALED THAT THE NON-CONFORMANCE IS/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 211123, SERIAL NUMBER (B)(4) SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: PERFORMED ALL THE REQUIRED TESTS; TESTS PASSED WITH SUCCESS. 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 MAKOPLASTY PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO). DURING THE CASE, CONNECTION ERROR NOT FIXABLE BY THE BYPASS CABLE OCCURRED CAUSING A DELAY >30 MINS. ANOTHER ROBOT HAD TO BE BROUGHT INTO THE ROOM TO COMPLETE THE CASE. THIS DID NOT NEGATIVELY IMPACT THE CASE, THE OUTCOME WAS SUCCESSFUL, AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46069 CPCI MOTION CONTROL ASSEMBLY 3.0 ROHS STEREOTACTIC DEVICE, ROBOTIC OLO MAKO SURGICAL CORP. ROB073

    Patients

    Seq Age Sex Outcome Treatment
    1 Other