BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 19431233 · Received May 30, 2024

    Report

    Report Number
    0001450997-2024-00006
    Event Type
    Injury
    Date Received
    May 30, 2024
    Date of Event
    March 15, 2024
    Report Date
    May 30, 2024
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO PRODUCT MALFUNCTION REPORTED OR SUSPECTED IN THE PROCEDURE THAT PRECEDED THIS EVENT GIVEN THAT THE MANUFACTURER HAS NOT BEEN MADE AWARE OF ANY PRODUCT COMPLAINTS FROM THE DATE OF THE SURGERY. DESPITE REQUESTS FOR THE LOT NUMBER OF THE DISPOSABLE PRODUCT OR THE CAPITAL EQUIPMENT INVOLVED IN THE PROCEDURE, NO LOT OR SERIAL NUMBERS HAVE BEEN PROVIDED. THE CAUSE OF THE INTRAGASTRIC HEMATOMA IS UNKNOWN BY THE MANUFACTURER. THE NOR-DOC-DRA-0025 RISK ANALYSIS WAS REVIEWED. THE CLOSEST RELATED RISK TO A HEMATOMA IS RISK ID 7.4.8.A (PATIENT INJURY FROM BLEEDING). THIS IS A RESIDUAL RISK OF THE PRODUCT AND THE MANUAL DOES CONTAIN A WARNING STATING "IMPROPER USE OF THE EHL PROBE COULD RESULT IN VESSEL PERFORATION FOLLOWED BY BLEEDING AND POSSIBLE INFECTION. OTHER COMPLICATIONS SUCH AS VESSEL STRICTURES RESULTING FROM EDEMA AND OCCLUSIONS CREATED BY STONE DEBRIS ARE ALSO POTENTIAL COMPLICATIONS OF EHL". THE RISKS ASSOCIATED WITH THE USE OF THE DEVICE LEADING TO INJURY DUE TO BLEEDING IS CONSIDERED LESS THAN REMOTE. IF FURTHER INFORMATION WAS TO BECOME AVAILABLE OR PRODUCT RETURNED FROM THE FIELD FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED AT THAT TIME. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED BY THE MANUFACTURER REGARDING HEMATOMAS FROM PROCEDURES WHERE THIS PRODUCT TYPE HAS BEEN USED. THERE ARE NO HEMATOMA OCCURRENCES LOGGED IN THE MAUDE DATABASE FOR THE FFK PRODUCT FAMILY BETWEEN 2012 AND 2022. THIS ADVERSE EVENT TYPE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT AND POST MARKET SURVEILLANCE SYSTEMS TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    ON 05/01/2024 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ADVERSE EVENT WHERE IT WAS REPORTED THAT "AFTER ERCP PROCEDURE ON (B)(6) 2024 PATIENT INDIGESTION FOR TWO DAYS, SO PROCEED GASTROSCOPY EXAM ON (B)(6) 2024, AND FOUND OUT LARGE AREA INTRAGASTRIC HEMATOMA AT POSTERIOR WALL. AFTER GIVEN MEDICINE CARE FOR A WEEK, PATIENT WAS STABLE AND DISCHARGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400031 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization