BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE 3-LUMEN EXTRACTION BALLOON V

    MDR report key: 7075610 · Received December 1, 2017

    Report

    Report Number
    2951238-2017-00756
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    November 14, 2017
    Report Date
    March 28, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FGE
    PMA / PMN Number
    PK091495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (REPORT 1 OF 2) THE BALLOON DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE CONFIRMED. A POTENTIAL FACTOR IS INCOMPATIBILITY WITH THE UNKNOWN MODEL SCOPE, LEADING TO MECHANICAL DAMAGE WHEN INSERTING AND MOVING THE BALLOON DEVICE. THE INSTRUCTION MANUAL FOR THE BALLOON SPECIFIES THE OLYMPUS SCOPE DIMENSIONS REQUIRED FOR USE WITH THE BALLOON, AND STATES ¿USE THIS INSTRUMENT ONLY IN COMBINATION WITH PRODUCTS RECOMMENDED BY OLYMPUS¿. ALSO, ¿NEVER USE EXCESSIVE FORCE TO OPERATE THE INSTRUMENT.¿ ¿DO NOT PULL THE TUBE WITH EXCESSIVE FORCE. OTHERWISE, THE BALLOON MAY BURST AND THE PIECES COULD REMAIN IN THE DUCT.¿ AS A PREVENTIVE MEASURE, ALSO ¿ALWAYS HAVE A SPARE INSTRUMENT AVAILABLE.¿ IN ADDITION, THE INSTRUCTION MANUAL HAS DIRECTIONS FOR PRE-PROCEDURE VISUAL AND TACTILE INSPECTION OF THE BALLOON DEVICE.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FGE TO LQR.

    Description of Event or Problem · 1

    (REPORT 1 OF 2) OLYMPUS WAS INFORMED THAT DURING AN ECRP PROCEDURE TO ADDRESS A COMMON BILE DUCT STONE, TWO EXTRACTION BALLOONS RUPTURED AFTER BEING DEPLOYED. FOR THE FIRST BALLOON DEVICE, ONE PIECE OF THE RUPTURED BALLOON WENT INTO THE PATIENT AND WAS SUCCESSFULLY RETRIEVED USING THE GUIDEWIRE ACCOMPANYING THE BALLOON DEVICE. THE PROCEDURE WAS COMPLETED USING OTHER ENDOSCOPIC DEVICES, AS WELL AS A CHOLANGIOGRAM TO VERIFY THAT ALL DEVICE FRAGMENTS WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853410 SINGLE USE 3-LUMEN EXTRACTION BALLOON V SINGLE USE 3-LUMEN EXTRACTION BALLOON FGE OLYMPUS MEDICAL SYSTEMS CORP. B-V243Q-A 76V

    Patients

    Seq Age Sex Outcome Treatment
    1