BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B1005, ACUCISE ENDOPYELOTOMY SYSTEM

    MDR report key: 6499095 · Received April 17, 2017

    Report

    Report Number
    2027111-2017-01718
    Event Type
    Malfunction
    Date Received
    April 17, 2017
    Date of Event
    March 17, 2017
    Report Date
    June 1, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    EYB
    UDI-DI
    00607915111663
    PMA / PMN Number
    K921838
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL HAS MULTIPLE PRODUCT CODES: EYB, DXT, KOG, EZB, KNY. THIS MODEL HAS MULTIPLE 510(K) CODES: K921838, K880987, K920030, K944135, K980987. THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED FOR EVALUATION. ENGINEERING WAS ABLE TO CONFIRM THE COMPLAINANT'S EXPERIENCE OF A RUPTURED BALLOON. THERE WAS DAMAGE OBSERVED ON THE COATING ON THE CUTTING WIRE, WHICH WAS CHARRED. IT IS LIKELY THAT THE BALLOON RUPTURED DUE TO HIGH THERMAL ACTIVITY OF THE CUTTING WIRE. THE INSTRUCTIONS FOR USE (IFU) STATES, "GENERATOR SETTING SHOULD BE AT 75 WATTS, PURE CUT MODE. NEVER USE A COAGULATION SETTING... THE POWER SETTING MUST NEVER EXCEED 100 WATTS... AND ...DO NOT EXCEED 5 SECONDS CONTINUOUS CUTTING TIME. TISSUE CHARRING, BALLOON RUPTURE, AND/OR WIRE BREAKAGE CAN OCCUR IF 5 SECONDS IS EXCEEDED." 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.

    Description of Event or Problem · 1

    CYSTO RPG URETEROSCOPY AND POSSIBLE ENDOPYELOTOMY - THE BALLOON BURST DURING SURGERY. IT WAS NOT KNOWN HOW MANY TIMES AND HOW LONG THE CUTTING WIRE WAS ACTIVATED. THE COORDINATOR NOTED THE PRODUCT WAS RELATED TO A BK024 ACUCISE PACK. TYPE OF INTERVENTION: OPENED A 2ND KIT. PATIENT STATUS: NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280407 B1005, ACUCISE ENDOPYELOTOMY SYSTEM EYB, DXT, KOG, EZB, KNY EYB APPLIED MEDICAL RESOURCES B1005 1269001 00607915111663

    Patients

    Seq Age Sex Outcome Treatment
    1