BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE MICS

    MDR report key: 9661936 · Received February 3, 2020

    Report

    Report Number
    3005985723-2020-00066
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    October 15, 2019
    Report Date
    February 3, 2020
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486030193
    PMA / PMN Number
    K142530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OILY RESIDUE IN/OUT AND AROUND THE HAND PIECE. (THIS EMAIL WAS SUBMITTED AS USER FEEDBACK). CASE TYPE: TKA. UPDATE: "WHAT TYPE OF EVENT ARE YOU REPORTING: USER FEEDBACK. DOES THE ISSUE APPEAR TO BE HARDWARE/INSTRUMENT OR SYSTEM/SOFTWARE RELATED? INSTRUMENT. EVENT DESCRIPTION: OILY RESIDUE IN/OUT AND AROUND THE HAND PIECE. DOES THE ISSUE APPEAR TO BE HARDWARE/INSTRUMENT OR SYSTEM/SOFTWARE RELATED? INSTRUMENT. WAS THE PATIENT UNDER ANESTHESIA? NO. PRODUCT INSPECTION: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPH PROVIDED IS ZOOMED IN AND SHOWS A BLACK MARK/SMUDGE ON WHAT APPEARS TO BE A MICS HANDPIECE. IT IS NOT POSSIBLE TO DETERMINE THE NATURE OF THE BLACK MARK FROM THE PHOTO PROVIDED. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS INDICATE 25 DEVICES WERE MANUFACTURED UNDER LOT K0CDW AND 24 DEVICES WERE ACCEPTED INTO FINAL STOCK ON 03/25/19. A REVIEW OF QT19-03-0120 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, LOT NUMBER 42080119 SHOWS NO ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSION: PER (B)(4), PREVENTIVE MAINTENANCE IS WHERE AN ACTION OCCURS THAT IDENTIFIES DEVICE DETERIORATION WHICH MAY COMPROMISE FUNCTION. UNDER PM CONDITIONS NO PATIENT WAS INVOLVED, AND NO ACTUAL OR POTENTIAL PATIENT HARM EXISTED FOR THE ALLEGED EVENT. THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPH PROVIDED IS ZOOMED IN AND SHOWS A BLACK MARK/SMUDGE ON WHAT APPEARS TO BE A MICS HANDPIECE. IT IS NOT POSSIBLE TO DETERMINE THE NATURE OF THE BLACK MARK FROM THE PHOTO PROVIDED. IT IS NOTED THAT THE REPORTED RESIDUE WAS DETECTED ON A HANDPIECE THAT APPEARS TO BE IN ROUTINE USE; THIS WAS NOT REPORTED AS AN OUT-OF-BOX ISSUE. THE ALLEGED FAILURE MODE COULD NOT BE CONFIRMED AS THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. NO ADDITIONAL INVESTIGATION OR SPECIFIC ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    OILY RESIDUE IN/OUT AND AROUND THE HAND PIECE. (THIS EMAIL WAS SUBMITTED AS USER FEEDBACK). CASE TYPE: TKA. UPDATE: "WHAT TYPE OF EVENT ARE YOU REPORTING: USER FEEDBACK DOES THE ISSUE APPEAR TO BE HARDWARE/INSTRUMENT OR SYSTEM/SOFTWARE RELATED? INSTRUMENT. EVENT DESCRIPTION: OILY RESIDUE IN/OUT AND AROUND THE HAND PIECE. DOES THE ISSUE APPEAR TO BE HARDWARE/INSTRUMENT OR SYSTEM/SOFTWARE RELATED? INSTRUMENT. WAS THE PATIENT UNDER ANESTHESIA? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124249 HANDPIECE MICS STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 209063 42080119 00848486030193

    Patients

    Seq Age Sex Outcome Treatment
    1 Other