BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8387175 · Received March 4, 2019

    Report

    Report Number
    3005985723-2019-00192
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    May 28, 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. 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 WO-01569982 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 #4202652-R." PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0A3B AND 23 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/23/2017. REVIEW OF QT17- 08 - 0083 REVEALED THAT THE NON-CONFORMANCE 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, LOT K0A3B SHOWS 08 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. COMPLAINT ID: (B)(4). CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN AN NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT. THIS IS NC1414517 AND CAPA 1450904.

    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
    179654 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010817/4202652 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization