BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B8634, UROWIRE SIX PACK 6/BX

    MDR report key: 6197130 · Received December 21, 2016

    Report

    Report Number
    2027111-2016-00906
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    May 10, 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

    INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL 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. BASED ON THE INSPECTION OF THE RETURNED UNIT, IT IS LIKELY THAT THE TUBING WAS DAMAGED DUE TO INTERACTION WITH AN INSTRUMENT, POSSIBLY THE CYSTOSCOPE. IT IS POSSIBLE THAT WHEN THE UNIT WAS REMOVED FROM THE SCOPE, IT MADE CONTACT WITH THE EDGE OF THE SCOPE, WHICH DAMAGED THE TUBING AND CAUSED IT 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.

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS TWO FDA PRODUCT CODES: EZB, KNY. THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED 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.

    Description of Event or Problem · 1

    CYSTOSCOPY, URETEROSCOPY - "DURING CYSTOSCOPY THE BLUE SHEATH SEPARATED AND SPLINTERED FROM THE GUIDEWIRE, DR WAS UNABLE TO USE ITEM FURTHER." PATIENT STATUS - "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844853 B8634, UROWIRE SIX PACK 6/BX EZB EZB APPLIED MEDICAL RESOURCES B8634 1258083 00607915113858

    Patients

    Seq Age Sex Outcome Treatment
    1