BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8502, M ALEXIS LAP SYS 6/BX

    MDR report key: 7049795 · Received November 21, 2017

    Report

    Report Number
    2027111-2017-02121
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    December 2, 2016
    Report Date
    November 21, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915119935
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THE COMPLAINANT'S EXPERIENCE OF A TEAR IN THE SHEATH. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY INSTRUMENTS THAT WERE USED DURING THE PROCEDURE. ENGINEERING DETERMINED THAT THE DAMAGE TO THE SHEATH WAS CAUSED BY OUTWARD STRETCHING OF THE FILM FROM THE PUNCTURE HOLE. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. THIS REPORT REPRESENTS THE INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED -LAP HEMI COLECTOMY. "THIS ALEXIS WAS NOTICED THAT IT WAS TORN, WHEN THE SCRUB NURSE UNPACK AND CHECK THE PRODUCT BEFORE USE, DURING THE SURGERY." PATIENT STATUS- NO PATIENT INJURY OR ILLNESS OCCURRED THAT WAS ASSOCIATED WITH THE COMPLAINT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828225 C8502, M ALEXIS LAP SYS 6/BX KGW KGW APPLIED MEDICAL RESOURCES C8502 1256507 00607915119935

    Patients

    Seq Age Sex Outcome Treatment
    1