BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EZDILATE BALLOON DILATOR (FW) 6-7-8

    MDR report key: 15311229 · Received August 29, 2022

    Report

    Report Number
    3003790304-2022-00176
    Event Type
    Malfunction
    Date Received
    August 29, 2022
    Date of Event
    September 16, 2021
    Report Date
    August 29, 2022
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    PNZ
    UDI-DI
    00821925033160
    PMA / PMN Number
    EXEMPT-KNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION, THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, BALLOON BURSTS MAY BE CAUSED BY OVER INFLATING THE BALLOON. THIS MAY BE DUE TO USING IMPROPER INFLATION DEVICE OR CUSTOMER ERROR. THE BALLOON MAY BE DAMAGED DURING INSERTION EITHER THROUGH SCRAPPING OR GOUGING WHEN PASSING THROUGH THE ENDOSCOPE OR ON STAPLES, IF PRESENT, IN THE PATIENT¿S INTESTINE. THIS MAY CAUSE IT TO BURST DURING INFLATION. ALL BALLOON CATHETERS ARE 100% LEAK TESTED DURING THE MANUFACTURING PROCESS. ANY LEAKING BALLOONS ARE SCRAPPED. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS WAS NOTIFIED OF AN OUT OF BOX FAILURE FOR ONE BD-400P-0880 BALLOON. WHILE THE BALLOON WAS INSIDE THE PATIENT, THE CUSTOMER INFLATED THE BALLOON TO 6MM AND THE BALLOON RUPTURED INSIDE THE PATIENT. THE RUPTURED BALLOON WAS RETRIEVED FROM INSIDE THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITH A SECOND BD-400P-0880. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147321 EZDILATE BALLOON DILATOR (FW) 6-7-8 BALLOON DILATOR PNZ GYRUS ACMI, INC. BD-400P-0880 513040D 00821925033160

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown