BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 8387246 · Received March 4, 2019

    Report

    Report Number
    3005985723-2019-00194
    Event Type
    Malfunction
    Date Received
    March 4, 2019
    Date of Event
    February 11, 2019
    Report Date
    November 3, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: IT WAS REPORTED THAT NOTICED AFTER THE CASE THAT THERE WAS GREASE ON THE MICS AND LOOKED INSIDE AND IT LOOKED DAMAGED. PRODUCT EVALUATION AND RESULTS: AS PER WORK ORDER (B)(4) AND CASE NUMBER (B)(4) THE ALLEGED FAILURE MODE WAS CONFIRMED. LOT #4202665 - RMA #(B)(4). UNABLE TO REPAIR MICS AS WITH THE NEW CABLE DID NOT FIX THE ISSUE. DISPOSITION - (RETURN TO VENDOR). RTV REASON: INTERNAL ISSUE WITH MICS. THE ALLEGED FAILURE WAS CONFIRMED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE (B)(4) DEVICES WERE MANUFACTURED UNDER LOT K0A3B AND (B)(4) DEVICES WERE ACCEPTED INTO FINAL STOCK ON 08/23/2017. REVIEW OF QT 17- 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 NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE ALLEGED FAILURE MODE WAS CONFIRMED. 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.

    Description of Event or Problem · 0

    NOTICED AFTER THE CASE THAT THERE WAS GREASE ON THE MICS AND LOOKED INSIDE AND IT LOOKED DAMAGED. CASE TYPE: TKA.

    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

    NOTICED AFTER THE CASE THAT THERE WAS GREASE ON THE MICS AND LOOKED INSIDE AND IT LOOKED DAMAGED. CASE TYPE: TKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180807 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 42010817 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization