BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B8634, UROWIRE, SIX PACK

    MDR report key: 6155420 · Received December 8, 2016

    Report

    Report Number
    2027111-2016-00897
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    October 24, 2016
    Report Date
    February 9, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    EZB
    UDI-DI
    00607915113858
    PMA / PMN Number
    K944135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS TWO FDA PRODUCT CODES: EZB, KNY. (B)(4) HAS JUST RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING CONFIRMED THE COMPLAINANT'S EXPERIENCE THAT THE BLUE COATING/TUBING HAD SEPARATED FROM THE WIRE. THE ROOT CAUSE OF THE TUBING SEPARATION COULD NOT BE DETERMINED. THE TUBING THAT HAD SEPARATED FROM THE WIRE APPEARED TO HAVE BEEN SHAVED OR CUT BY A SHARP INSTRUMENT OR SURFACE. IT IS POSSIBLE THAT WHEN THE UNIT WAS REMOVED FROM THE SCOPE, IT MADE CONTACT WITH THE EDGE OF THE SCOPE, WHICH CAUSED THE TUBING TO SEPARATE FROM THE WIRE. 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. IN ACCORDANCE TO 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    CYSTOSCOPY, URETEROSCOPY, DYELOGRAM - "BLUE COATING SEPARATED FROM WIRE WHEN SURGEON TRIED TO REMOVE THE WIRE VIA THE SCOPE. WIRE GOT STUCK AND HAD TO BE REMOVED WITH FORCE." PATIENT STATUS - "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806997 B8634, UROWIRE, SIX PACK EZB, KNY EZB APPLIED MEDICAL RESOURCES B8634 1258083 00607915113858

    Patients

    Seq Age Sex Outcome Treatment
    1