BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON CONTROLLER PB-30

    MDR report key: 10447901 · Received August 25, 2020

    Report

    Report Number
    3001722928-2020-00012
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    July 24, 2020
    Report Date
    January 25, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    FDF
    PMA / PMN Number
    K153483
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    FUJIFILM CONDUCTED A DETAILED INVESTIGATION OF THE DEVICE AND WAS UNABLE TO IDENTIFY THE CAUSE. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO FUJIFILM MEDICAL SYSTEMS USA INC. (FMSU) FOR INSPECTION. THE INVESTIGATION IS IN PROGRESS. IF ANY ADDITIONAL RELEVANT INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON JULY 27, 2020 FUJIFILM MEDICAL SYSTEMS USA INC (FMSU) WAS INFORMED THAT OVERPRESSURE OCCURRED DURING A PATIENT PROCEDURE; FUJIFILM CORPORATION RECEIVED THE NOTIFICATION OF THE EVENT ON JULY 30, 2020. THE PATIENT WAS UNDERGOING A DOUBLE BALLOON COLONOSCOPY FOR DIAGNOSTIC PURPOSES. AT THE END OF THE PROCEDURE, THE PHYSICIAN OBSERVED THE BALLOON DID NOT DEFLATE. THE BALLOON CONTROLLER ALARMED, HOWEVER THE BALLOON CONTINUED TO INFLATE IN THE PATIENT'S COLON EVEN WHEN THE BUTTON ON THE HANDLE WAS PRESSED TO DEFLATE. THE PHYSICIAN HAD TO PULL THE BALLOON OUT FROM THE PATIENT WHEN IT WAS INFLATED. IT WAS INDICATED THAT AS THE PATIENT CAME OUT OF ANESTHESIA HE APPEARED TO BE EXPERIENCING ABDOMINAL DISCOMFORT AND YELLED IN PAIN. THE PATIENT WAS DISCHARGED, AND THERE WAS NO ADDITIONAL TREATMENT FOR THE PATIENT'S PAIN AND THE PATIENT DID NOT RECALL ANYTHING THAT OCCURRED PRIOR. THE CUSTOMER INDICATED THAT A SIMILAR ISSUE OCCURRED THE MONTH PRIOR DURING A PRE-USE INSPECTION; THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS SENT FOR INSPECTION TO CLINICAL ENGINEERING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT PROCESS AND EQUIPMENT. THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT; THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915872 BALLOON CONTROLLER PB-30 BALLOON CONTROLLER FDF FUJIFILM CORPORATION PB-30 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1