BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8386480 · Received March 4, 2019

    Report

    Report Number
    3005985723-2019-00191
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    June 13, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. REPORTED EVENT: IT WAS REPORTED THAT TRIED THE FIRST MICS AND IT SAID MICS CABLE CONNECTION ERROR, TRIED THE SECOND ONE AND SAME THING. WORKED ON THE THIRD MICS. I TESTED BOTH NUMEROUS TIMES AFTER THE CASE ALONG WITH MULTIPLE MICS STATUS CHECKS AND THEY BOTH FAILED. PRODUCT EVALUATION AND RESULTS: AS PER WORK ORDER (B)(4) AND CASE NUMBER (B)(4) THE ALLEGED FAILURE MODE WAS CONFIRMED. 1. SUCCESSFULLY PERFORMED MICS CABLE REPLACEMENT PER D06917.MICS CAN BE RETURNED TO STOCK AS A 209063 LOT #4202791-R." PRODUCT HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0A3C AND 23 DEVICES WERE ACCEPTED INTO FINAL STOCK ON (B)(6) 2017. A REVIEW OF QT17-09-0021 REVEALED THAT THE ISSUE IS NOT RELATED TO THE FAILURE ALLEGED IN THIS COMPLIANT. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 209063, PRODEX LOT K0A3C SHOWS 09 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. THE RELATED COMPLAINTS ARE (B)(4). CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THAT NC 1414517 AND CAPA 1450904 ARE ASSOCIATED WITH THE FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    TRIED THE FIRST MICS AND IT SAID MICS CABLE CONNECTION ERROR, TRIED THE SECOND ONE AND SAME THING. WORKED ON THE THIRD MICS. I TESTED BOTH NUMEROUS TIMES AFTER THE CASE ALONG WITH MULTIPLE MICS STATUS CHECKS AND THEY BOTH FAILED. CASE TYPE: TKA. SURGICAL DELAY: 15 MINUTES. SURGICAL DELAY WAS REPORTED AS 15 MINUTES. WAS THE PATIENT UNDER ANESTHESIA AT THE TIME OF THE ISSUE? (YES/NO): AS PER THE MPS: YES THE PATIENT WAS UNDER ANESTHESIA, HOWEVER, I ASKED THE SURGICAL TECH MULTIPLE TIMES TO DRAPE THE ROBOT AND PERFORM MICS STATUS CHECK PRIOR TO THE PATIENT ENTERING THE ROOM. I NOTIFIED THE SURGEON THAT WE WERE NOT ABLE TO DRAPE THE ROBOT, CHECK THE MICS, OR PERFORM REGISTRATION AS NORMAL AND HE IS AWARE THAT THE TECH WAS NOT FULLY COOPERATING.

    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

    TRIED THE FIRST MICS AND IT SAID MICS CABLE CONNECTION ERROR, TRIED THE SECOND ONE AND SAME THING. WORKED ON THE THIRD MICS. I TESTED BOTH NUMEROUS TIMES AFTER THE CASE ALONG WITH MULTIPLE MICS STATUS CHECKS AND THEY BOTH FAILED. CASE TYPE: TKA. SURGICAL DELAY: 15 MINUTES. SURGICAL DELAY WAS REPORTED AS 15 MINUTES. WAS THE PATIENT UNDER ANESTHESIA AT THE TIME OF THE ISSUE? (YES/NO): AS PER THE MPS: YES, THE PATIENT WAS UNDER ANESTHESIA; HOWEVER, I ASKED THE SURGICAL TECH MULTIPLE TIMES TO DRAPE THE ROBOT AND PERFORM MICS STATUS CHECK PRIOR TO THE PATIENT ENTERING THE ROOM. I NOTIFIED THE SURGEON THAT WE WERE NOT ABLE TO DRAPE THE ROBOT, CHECK THE MICS, OR PERFORM REGISTRATION AS NORMAL AND HE IS AWARE THAT THE TECH WAS NOT FULLY COOPERATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179954 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42060817/4202791 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization