BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIGATION COMPUTER, TGS V2 W/ SOFTWARE

    MDR report key: 6582216 · Received May 22, 2017

    Report

    Report Number
    3005985723-2017-00226
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    May 8, 2017
    Report Date
    July 9, 2017
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 AND FINAL REPORT SUBMITTED TO UPDATE SECTIONS BASED ON THE RESULTS OF INVESTIGATION. REPORTED EVENT: THE REPORTED DEVICE WAS A NAVIGATION COMPUTER, TGS V2 W/ SOFTWARE, CATALOG# 202498, LOT# 274498-1 WHICH WAS NOT SENDING A VIDEO SIGNAL TO EITHER OF THE MONITORS. DEVICE EVALUATION AND RESULTS: THE ISSUE WAS INVESTIGATED AND DOCUMENTED IN GSP (B)(4). THE ISSUE COULD NOT BE DUPLICATED. THE 2U COMPUTER WAS REPLACED AS A PRECAUTION. PREVENTATIVE MAINTENANCE WAS ALSO PERFORMED AND THE SYSTEM DECLARED READY FOR CLINICAL USE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT NAVIGATION COMPUTER, TGS V2 W/ SOFTWARE, CATALOG# 202498, LOT# 274498 WAS REWORKED ON JULY 13, 2016; ALL INSPECTIONS PASSED AND THE ASSEMBLY WAS DECLARED READY FOR CLINICAL USE. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN TRACKWISE RELATED TO P/N 202498, SERIAL NUMBER 274498-1 SHOWS 1 ADDITIONAL COMPLAINT RELATED TO THE FAILURE IN THIS INVESTIGATION. THE COMPLAINT IS TRACKWISE PR# 895333. CONCLUSIONS: THE FAILURE MODE OF NO SIGNAL TO ANY OF THE MONITORS COULD NOT BE DUPLICATED BY THE FSE. THE ISSUE OCCURRED BEFORE A CASE AND RESULTED IN A 30 MINUTE DELAY AND ULTIMATELY CANCELLATION. 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.

    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

    LOT# 274498-1. NO VIDEO ON EITHER MONITOR. ***UPDATE***(B)(4). WHEN WAS ISSUE NOTICED? PRIOR. WAS THERE PATIENT INVOLVEMENT? ANY PATIENT HARM? STATE ANY ADVERSE CONSEQUENCES. NO PT HARM. ANY SURGICAL DELAY? >30 MIN) CASE CANCELED. WAS PROCEDURE COMPLETED SUCCESSFULLY? NO. POSTPONED TILL (B)(6) 2017. WAS PROCEDURE COMPLETED MANUALLY? NO. THE PATIENT WAS UNDER ANESTHESIA WHEN THE CASE WAS CANCELLED.

    Description of Event or Problem · 1

    LOT# 274498-1 NO VIDEO ON EITHER MONITOR. APPLICATION (PKA/THA/TKA) PKA. WHEN WAS ISSUE NOTICED? PRIOR WAS THERE PATIENT INVOLVEMENT? ANY PATIENT HARM? STATE ANY ADVERSE CONSEQUENCES. NO PT HARM. ANY SURGICAL DELAY? >30 MIN) CASE CANCELED. WAS PROCEDURE COMPLETED SUCCESSFULLY? NO. POSTPONED TILL (B)(6) 2017. WAS PROCEDURE COMPLETED MANUALLY? NO. THE PATIENT WAS UNDER ANESTHESIA WHEN THE CASE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363604 NAVIGATION COMPUTER, TGS V2 W/ SOFTWARE STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 274498-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization