BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO® ROBOTIC ARM - MICS

    MDR report key: 8768055 · Received July 8, 2019

    Report

    Report Number
    3005985723-2019-00497
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 12, 2019
    Report Date
    November 27, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS D.3, G.1, G.4, G.7, H.2, H.3, H.6, H.10 AND H.11 BASED ON THE RESULTS OF INVESTIGATION. AN EVENT REGARDING INACCURATE RESECTION INVOLVING 3.0 RIO ROBOTIC ARM - MICS, CATALOG: 209999 WAS REPORTED. METHOD & RESULTS: DEVICE HISTORY REVIEW: A REVIEW OF THE DHR ASSOCIATED WITH RIO 359 FOUND QUALITY INSPECTION PROCEDURES SUCCESSFULLY PASSED. COMPLAINT HISTORY: A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO SIMILAR COMPLAINTS FOR PKA SOFTWARE - INACCURATE RESECTION. CONCLUSION: NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    CASE NUMBER: (B)(4), MPS (B)(6). REPORTED THAT PKA POST HOLE CUTS ARE NOT LINING UP CORRECTLY. CASE TYPE: PKA. CAN YOU PLEASE QUANTIFY HOW FAR OFF THE PKA POST HOLES WERE VS PLANNED? AS PER THE MPS: "PKA HOLES WERE 5MM LATERAL OF PLANNED CUT". SURGICAL DELAY: "ROUGHLY 10 MINUTES".

    Additional Manufacturer Narrative · 1

    AS PART OF THE 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.

    Description of Event or Problem · 1

    CASE NUMBER: (B)(6), MPS (B)(6) REPORTED THAT PKA POST HOLE CUTS ARE NOT LINING UP CORRECTLY. CASE TYPE: PKA. CAN YOU PLEASE QUANTIFY HOW FAR OFF THE PKA POST HOLES WERE VS PLANNED? AS PER THE MPS: "PKA HOLES WERE 5MM LATERAL OF PLANNED CUT". SURGICAL DELAY: "ROUGHLY 10 MINUTES"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561204 3.0 RIO® ROBOTIC ARM - MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization