BEUDAMED
    FDA Adverse Event Death Summary report: N

    BALLOON CONTROL UNIT

    MDR report key: 10238708 · Received July 7, 2020

    Report

    Report Number
    8010047-2020-03957
    Event Type
    Death
    Date Received
    July 7, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 22, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDA
    PMA / PMN Number
    K071254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B2: DATE OF DEATH - (B)(6) 2020. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS ISSUE AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), THEREFORE OMSC CANNOT INVESTIGATE THE DEVICE. OMSC INVESTIGATED THIS EVENT BASED ON INFORMATION PROVIDED BY THE USER FACILITY AND CONCLUDED THAT THE DEVICE HAD NO MALFUNCTION BECAUSE THE CUSTOMER DIDN¿T REPORT ANY DEVICE PROBLEM, BEEP SOUND DURING PROCEDURE, OR EMERGENCY LAMP TURNING ON. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    ON (B)(6) 2020, A PATIENT DIED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) FOR POSTOPERATIVE BILE DUCT STRICTURE USING THE SUBJECT OBCU (BALLOON CONTROL UNIT) AND ST-SB1S (SINGLE-USE SPLINTING TUBE). DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE PATIENT'S CONDITION WAS GETTING DETERIORATED AND AIR EMBOLISM SPREAD THROUGHOUT THE PATIENT'S BODY. THE FACILITY TRIED RESUSCITATION, BUT IT DIDN'T WORK. THE PHYSICIAN SURMISED THAT SEALING THE INTESTINE BY THE BALLOON HAD INCREASED THE INTERNAL PRESSURE OF THE INTESTINE AND IT RESULTED IN THE AIR EMBOLISM. THIS IS THE SECOND ERCP THAT THE PATIENT UNDERWENT. ACCORDING TO THE NUMBER OF OLYMPUS DEVICES THAT HAVE/MAY HAVE CONTRIBUTED TO THE EVENT, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) IS SUBMITTING 2 MEDICAL DEVICE REPORTS. THIS IS 1 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706205 BALLOON CONTROL UNIT BALLOON CONTROL UNIT FDA OLYMPUS MEDICAL SYSTEMS CORP. OBCU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death SIF-H290S, UNKNOWN SERIAL| ST-SB1S, UNKNOWN LOT