BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 23357261 · Received October 22, 2025

    Report

    Report Number
    0001450997-2025-00005
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 20, 2025
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020448
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2025 NTI WAS MADE AWARE OF AN ALLEGED EVENT IN WHICH A DOCTOR "PERFORATED THE BILE DUCT - HE WAS UNSURE HOW AND SETTINGS ON EHL WERE 5 & LOW. HE DID NOT BLAME OUR DEVICES." THE DOCTOR INDICATED A "BILIARY FC STENT WAS PLACED, PATIENT WILL NOW BE MONITORED CLOSELY TO SEE IF PERFORATION HEALS ON ITS OWN." NTI REQUESTED INFORMATION ABOUT THE SINGLE USE DEVICE INCLUDING THE LOT NUMBER AND ANY UPDATES REGARDING THE STATUS OF THE PATIENT'S INJURIES HOWEVER, NO ADDITIONAL FEEDBACK WAS AVAILABLE FROM THE CUSTOMER. BASED ON SHIPPING INFORMATION PROVIDED BY THE DISTRIBUTOR, NTI ASSESSED THREE PROBABLE LOTS MANUFACTURED BETWEEN FEBRUARY 2023 AND JULY OF 2024 (16938, 17478, AND 18026). UPON PRODUCT REVIEW, THERE WAS NOTHING OUT OF THE NORM NOTED IN EITHER PRODUCT QUALITY OR PERFORMANCE. NO OTHER INJURIES HAVE BEEN REPORTED IN CONNECTION TO THESE LOTS. NOR-DOC-DRA-0020 RISK ANALYSIS REV T WAS REVIEWED. RISK 1.10(A) CONSIDERS THE RISK OF PERFORATION RESULTING IN A LIFE-THREATENING CONDITION WHEREAS 1.10(B) CORRESPONDS TO A PERFORATION OF THE BILIARY DUCTAL SYSTEM LEADING TO A MINOR INJURY. THE MANUAL WARNS AGAINST USE OF THE DEVICE BY UNSKILLED USERS AND ADVISES THE USER TO NOT PLACE THE PROBE DIRECTLY AGAINST TISSUE AS THESE WERE FORESEEABLE HAZARDS IDENTIFIED IN THE RISK ANALYSIS. A CLINICAL EVALUATION WAS PERFORMED PER (B)(4) AND IT WAS IDENTIFIED THAT LITHOTRIPSY OUTWEIGHS THE RISK OF INJURY. AS THE SINGLE USE DEVICE WAS NOT RETURNED FOR EVALUATION, IT IS HARD TO DETERMINE WHAT LED TO THE PERFORATION, HOWEVER, THE USER STATED THEY DID NOT BELIEVE THE PERFORATION WAS CAUSED BY OUR PRODUCT. SEVERAL ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME RELATING TO THE INJURY OR PATIENT. PERFORATIONS MAY BE CAUSED BY STONES OR TRAUMA DURING THE PROCEDURE, BUT WITHOUT MORE INFORMATION NO CONCLUSIONS COULD BE MADE AT THIS TIME. IN THE PAST THREE YEARS, NTI HAS NOT BEEN NOTIFIED OF ANY OTHER SERIOUS INJURIES OR DEATH RELATED TO PERFORATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 09/24/2025 IT WAS REPORTED TO NORTHGATE TECHNOLOGIES INC. THAT "[THE] DR ADVISED THEY HAVE PERFORATED THE BILE DUCT - HE WAS UNSURE HOW AND SETTINGS ON EHL WERE 5 & LOW. HE DID NOT BLAME OUR DEVICES." A STENT WAS PLACED AND THE " PATIENT WILL NOW BE MONITORED CLOSELY TO SEE IF PERFORATION HEALS ON ITS OWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232223 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other