BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMILEY RETRACTOR

    MDR report key: 9295411 · Received November 8, 2019

    Report

    Report Number
    3005985723-2019-00795
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 17, 2019
    Report Date
    December 30, 2019
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OLO
    UDI-DI
    00848486031916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: SMILEY RETRACTOR DAMAGED AND NEEDS REPLACEMENT. CASE TYPE: PKA (MICS). PRODUCT EVALUATION AND RESULTS: VISUAL INSPECTION: CONFIRMATION OF SMILEY RETRACTOR DAMAGED. PRODUCT HISTORY REVIEW: REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE 100 DEVICES WERE MANUFACTURED UNDER LOT NO 31670, AND 100 WERE ACCEPTED INTO FINAL STOCK ON 02/15/2017. NO NON-CONFORMANCES WERE IDENTIFIED DURING INSPECTION. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS IN CATSWEB AND TRACKWISE RELATED TO P/N 210192, LOT NUMBER 31670, SHOWS 00 ADDITIONAL COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. CONCLUSIONS: THE EVENT WAS CONFIRMED. CORRECTIVE ACTION/PREVENTIVE ACTION: A REVIEW OF STRYKER¿S NC/CAPA DATABASE INDICATED THERE HAVE BEEN NO NC AND CAPA ASSOCIATED WITH THE PRODUCT AND FAILURE MODE REPORTED IN THIS EVENT.

    Description of Event or Problem · 0

    SMILEY RETRACTOR DAMAGED AND NEEDS REPLACEMENT. CASE TYPE: PKA (MICS).

    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

    SMILEY RETRACTOR DAMAGED AND NEEDS REPLACEMENT. CASE TYPE: PKA (MICS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093660 SMILEY RETRACTOR STEREOTAXIC DEVICE, ROBOTICS OLO MAKO SURGICAL CORP. 31670 00848486031916

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization