BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 24581689 · Received March 12, 2026

    Report

    Report Number
    0001450997-2026-00003
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 9, 2026
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    PMA / PMN Number
    K130368
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 17TH NTI REQUESTED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR REGARDING A VIDEO OF THE INCIDENT, THE EXPERIENCE OF THE USER, AND ANY ADDITIONAL HEALTH EFFECTS. PER THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED NO HEALTH CONSEQUENCES, AND THE USER SUFFERS INFREQUENT PAINS IN HAND AND FOREARM. THE USERS SPECIFIED IN THEIR RESPONSE RECEIVED ON FEBRUARY 20, 2026 THAT THE PROBE WAS SHOWING SIGNS OF MALFUNCTION PRIOR TO THE INCIDENT. THE DISTRIBUTOR ALSO RECEIVED INFORMATION THAT THE PROBE WAS WORKING AS INTENDED ORIGINALLY, AND THAT IT APPEARS THE SHOCK CAME FROM THE ELECTRICAL PULSE OCCURRING ON THE SHAFT OF THE PROBE RATHER THAN THE DISTAL TIP. A KINK/BREAK IN THE PROTECTIVE COATING, OR EXCESSIVE FORCE, COULD CAUSE THE PROBE TO ARC OUTSIDE OF THE INTENDED LOCATION AT THE TIP. PER THE PRODUCT OPERATOR'S MANUAL, (B)(4), "THE "REPLACE PROBE" MESSAGE IS A GENERAL INDICATOR OF EXPECTED PROBE LIFE. IT IS NOT TO BE INTERPRETED THAT PROBES CANNOT FAIL BEFORE THIS MESSAGE APPEARS. USE OF ANY PROBE SHOULD BE STOPPED IMMEDIATELY IF A MALFUNCTION OCCURS, OR IF ANY OF THE CONDITIONS STATED IN THE WARNINGS ARE OBSERVED. DO NOT DISCONNECT AND ATTEMPT TO RE-USE THE EHL PROBE. DISCONNECTING THE PROBE OR POWERING DOWN THE UNIT ERASES ALL OF THE INTERNAL STORED DATA REGARDING THE USEFUL LIFE OF THE PROBE, MAKING THE "REPLACE PROBE" MESSAGE INVALID." THE DEVICE HISTORY RECORD WAS REVIEWED, AND PROBE LOT 18855 MET ALL REQUIREMENTS FOR RELEASE. MAKING PHYSICAL CONTACT WITH A DAMAGED PROBE AND COMPRESSING THE FOOT PEDAL TO INDUCE A SPARK COULD RESULT IN A SHOCK TO THE USER. AS THE PROBE WAS DISCARDED PER THE USER, NO PHYSICAL PROBE ASSESSMENT WAS POSSIBLE BY NTI. USE OF A DAMAGED/ DEFECTIVE PROBE COULD RESULT IN AN INJURY TO THE PATIENT OR THE USER. THE PRODUCT RISK FILE, (B)(4), IDENTIFIES RISK OF SHOCK FROM CONTACT WITH THE PROBE OR EXTENDER CABLE. A CLINICAL EVALUATION, (B)(4), DETERMINED THE BENEFITS OF LITHOTRIPSY OUTWEIGHED THE RISKS. ISSUE-2026-0006 WAS OPENED VIA OUR CAPA SYSTEM TO FURTHER EVALUATE THE ISSUE/RISK. IF ANY NEW INFORMATION IS ACQUIRED OR THE PRODUCT IS RETURNED, A MEDWATCH UPDATE WOULD BE PROVIDED.

    Description of Event or Problem · 0

    ON FEBRUARY 15TH, 2026 NORTHGATE TECHNOLOGIES INC. WAS INFORMED OF AN ALLEGED EVENT FROM BOSTON SCIENTIFIC CORPORATION READING " RECORD ID: (B)(6) - EVENT DATE: 2026-2-4. RETURNED PRODUCT EXPECTED: NO. TYPE OF PROCEDURE: NO VALUE FOUND. RELATED PRODUCT UPN #: M00546620. RELATED PRODUCT FAMILY: AUTOLITH TOUCH EHL PROBES. EVENT DESCRIPTION: IT WAS REPORTED THAT: PLEASE BE INFORMED OF AN INCIDENT THAT OCCURRED ON FEBRUARY 4TH, OF WHICH I BECAME AWARE TODAY, INVOLVING AN AUTOLITH EHL M00546620 LITHOTRIPSY PROBE - LOT 18855 USED WITH A SPYSCOPE M00546610 - LOT 40396023. THE CHOSEN PROGRAM WAS 30 PULSES FOR "HIGH" POWER. SINCE THEN, DR. (REDACTED NAME) HAS BEEN COMPLAINING OF PAIN IN HIS ARM AND HAND FOLLOWING ELECTRIC SHOCKS, WHICH YOU CAN SEE IN THE ATTACHED VIDEO. UNFORTUNATELY, THE CLIENT DID NOT KEEP THE PROBE. THE PATIENT IS DOING WELL. NO CONSEQUENCES FOR HIM ARE KNOWN AS OF TODAY. THE SERIAL NUMBERS FOR THE DIFFERENT CONSOLES ARE: · AUTOLITH M00546680 / (B)(6). SPYGLASS M00546650 / (B)(6). DUODENOSCOPE(B)(6). DEVICE/PROCEDURE OUTCOME: ORIGINAL DEVICE USED, VPROCEDURE COMPLETED. PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT AS REPORTED. DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM AS REPORTED. PATIENT CODES: 9205: PAIN, 9087: ELECTRIC SHOCK. COUNTRY OF EVENT: FRANCE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638223 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0 18855

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other