BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR 5 OP HYSTERSCOPE

    MDR report key: 7135815 · Received December 20, 2017

    Report

    Report Number
    1219930-2017-10252
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    May 25, 2017
    Report Date
    December 20, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    NWW
    PMA / PMN Number
    K112134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. A VISUAL INSPECTION WAS PERFORMED AND SHOWED DISTAL TIP DAMAGE, DENT IN THE SHEATH, AND A DAMAGED LEAKY STOPCOCK. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS ¿¿ CAREFUL INSPECTION OF THE OPERATIVE HYSTEROSCOPE BEFORE AND AFTER THE PROCEDURE FOR POSSIBLE SIGNS OF DAMAGE. IMMEDIATE DETECTION AND REPAIR OF MINOR DAMAGE WILL EXTEND THE LIFE OF THE OPERATIVE HYSTEROSCOPE.¿ DAMAGE MAY OCCUR IF THE HYSTEROSCOPE IS HANDLED ROUGHLY DURING USE. EXCESSIVE FORCES MAY RESULT IN TRAUMATIC INSERTION, CHIPPING PARTICLES OF THE OPTICAL GLASS, OR OTHER DAMAGE TO THE UNIT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE USED DEVICE HAD FOGGY LENS. NO ADDITIONAL INFORMATION GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915979 TRUCLEAR 5 OP HYSTERSCOPE HYSTEROSCOPE ACCESSORIES NWW COVIDIEN LP LLC NORTH HAVEN 72202976

    Patients

    Seq Age Sex Outcome Treatment
    1