BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 RIO ROBOTIC ARM - MICS

    MDR report key: 9883856 · Received March 26, 2020

    Report

    Report Number
    3005985723-2020-00184
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 5, 2020
    Report Date
    July 2, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED ¿THE GREEN WAS NOT BEING REMOVED DURING A PKA CASE. THIS WAS EXTREMELY FRUSTRATING AND MADE THE CASE MORE DIFFICULT. WITH TKA WHEN THIS HAPPENS ITS A LOT EASIER TO TELL WHAT YOU STILL NEED TO GET. PKA IS BRUTAL. CASE TYPE: PKA (MICS)¿ PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORMED AS CASE SESSION DATA WAS NOT PROVIDED. PRODUCT HISTORY REVIEW: A REVIEW OF DEVICE HISTORY RECORDS SHOWS THAT (B)(6) WAS INSPECTED ON 13/05/2013 AND WAS HANDLED VIA NPR. A REVIEW OF THE DATA REVEALED THAT THE NON-CONFORMANCES IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLAINT. COMPLAINT HISTORY REVIEW; A SEARCH OF THE COMPLAINT DATABASE UNDER DEVICE IDENTIFICATION PN 209999 REPORTS NO SIMILAR COMPLAINTS FOR PKA SOFTWARE - SOFTWARE ERROR. CONCLUSIONS: THE FAILURE COULD NOT BE DETERMINED AS NO CASE SESSION DATA OR LOGS WERE PROVIDED AFTER THREE COMMUNICATION ATTEMPTS WERE MADE. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION IS RECEIVED THEN THE COMPLAINT WILL BE REOPENED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE GREEN WAS NOT BEING REMOVED DURING A PKA CASE. THIS WAS EXTREMELY FRUSTRATING AND MADE THE CASE MORE DIFFICULT. WITH TKA WHEN THIS HAPPENS ITS A LOT EASIER TO TELL WHAT YOU STILL NEED TO GET. PKA IS BRUTAL. CASE TYPE: PKA (MICS).

    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.

    Description of Event or Problem · 1

    THE GREEN WAS NOT BEING REMOVED DURING A PKA CASE. THIS WAS EXTREMELY FRUSTRATING AND MADE THE CASE MORE DIFFICULT. WITH TKA WHEN THIS HAPPENS ITS A LOT EASIER TO TELL WHAT YOU STILL NEED TO GET. PKA IS BRUTAL. CASE TYPE: PKA (MICS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346933 3.0 RIO ROBOTIC ARM - MICS ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MAKO SURGICAL CORP. 209999 00848486030407

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O