BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 25257120 · Received May 22, 2026

    Report

    Report Number
    0001450997-2026-00006
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 22, 2026
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    PMA / PMN Number
    K130368
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON 04/28 ADDITIONAL QUESTIONS WERE PROVIDED FROM REGULATORY AFFAIRS AS PROVIDED: 1.) WHAT PROCEDURE WAS BEING PERFORMED? 2.) WHAT SPYSCOPE MODEL WAS IN USE? 3.) WHERE WAS THE NURSE MAKING CONTACT WITH THE PROBE? AT THE DAMAGE SITE? AT THE HANDLE? 4.) WHAT LED TO THE FOOT PEDAL BEING PRESSED WHILE HANDLING THE PROBE? A. WAS THE USER EXPERIENCED WITH THE EQUIPMENT? 5.) THE COMPLAINT SPECIFIES THE NURSE WAS ELECTROCUTED WHICH IS DEFINED AS "TO KILL OR SEVERELY INJURE BY ELECTRIC SHOCK" VERSUS THE DEFINITION OF SHOCK IS "A SUDDEN, OFTEN PAINFUL, PHYSICAL REACTION CAUSED BY AN ELECTRIC CURRENT PASSING THROUGH THE BODY". CAN YOU CONFIRM IF THE NURSE WAS SHOCKED OR ELECTROCUTED? A. WHAT ARE THE SUSTAINED INJURIES BY THE NURSE? ARE THEY PERSISTENT/PROLONGED? 6.) WAS THERE AN INDICATION THE PROBE WAS DAMAGED OR MALFUNCTIONING PRIOR TO ITS REMOVAL FROM THE SPYSCOPE? 7.) HOW MANY SHOTS WERE FIRED ON THE PROBE BEFORE IT WAS REMOVED? 8.) IS THE PRODUCT BEING RETURNED FOR INVESTIGATION? THROUGH THE COMMUNICATION ABOVE, THE USER INJURY IS THE RESULT OF THE FOOT PEDAL BEING PRESSED TO CREATE AN ELECTRICAL IMPULSE WHILE THE NURSE WAS REMOVING THE DAMAGED PROBE FROM THE SPYSCOPE. NO ADDITIONAL INJURY WAS SPECIFIED FROM THE CUSTOMER, JUST THAT THE NURSE WAS ON LEAVE DUE TO THE SHOCK. THE OPERATORS MANUAL NOR-SPEC-6100-1230 HAS THE FOLLOWING WARNINGS/CAUTIONS TO TRY AND WARN PATIENTS AND USERS OF THE RISKS INVOLVED WITH THE PROCEDURE: "ELECTROHYDRAULIC LITHOTRIPTER PROBES ARE LIMITED LIFE, SINGLE USE DEVICES. IF ANY OF THE FOLLOWING CONDITIONS ARE NOTED, REGARDLESS OF THE "REPLACE PROBE" MESSAGE, STOP USING IMMEDIATELY AND USE A NEW PROBE: FIRING (OR ARCING) BEHIND THE TIP, EJECTION OF TIP OR INSULATION MATERIAL, ARCING ALONG THE WIRES OR INSIDE / OUTSIDE OF THE CONNECTOR. SUSTAINED USE OF THE PROBES AT HIGHER POWER SETTINGS WILL SIGNIFICANTLY SHORTEN THE USEFUL LIFE OF THE PROBE. 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." AS THE PROBE WAS NOT RETURNED, NO FURTHER INVESTIGATION COULD BE PERFORMED. CAPA-2026-0006 WAS OPENED PREVIOUSLY TO EVALUATE USER SHOCK. AS PART OF THE REVIEW, THE RISK ANALYSIS NOR-DOC-DRA-0025 REV T WAS REVIEWED. THE RISK ANALYSIS IDENTIFIES THE RISK OF SHOCK FROM CONTACT WITH THE PROBE OR EXTENDER CABLE. FURTHER UPDATES ARE PENDING IN THE RISK ANALYSIS AS A RESULT OF THE EVENT TO BETTER DIFFERENTIATE THE RISK TO THE USER FROM THE PATIENT. A CLINICAL EVALUATION, NOR-DOC-CER-0002, DETERMINED THE BENEFITS OF LITHOTRIPSY OUTWEIGHED THE RISKS. A CURRENT DRAFT OF THE MANUAL ALSO INCLUDES AN ADDITIONAL WARNING TO "DISCONNECT" THE PROBE PRIOR TO REMOVAL. THIS WAS ADDED TO REDUCE THE RISK OF SIMILAR OCCURENCES IN THE FUTURE. AS THE PROBE WAS DISCARDED PER THE USER, NO PHYSICAL PROBE ASSESSMENT WAS POSSIBLE BY NTI. WITHOUT PRODUCT RETURN, AND NO LOT/BATCH INFORMATION PROVIDED, ALL INFORMATION PROVIDED HAS BEEN EVALUATED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE WHICH IMPACTS THE INFORMATION SITED ABOVE, AN UPDATE REPORT CAN BE PROVIDED.

    Description of Event or Problem · 0

    ON (B)(6) 2026 A SALES REPRESENTATIVE FROM A CUSTOMER REACHED OUT REGARDING AN INJURY EXPERIENCED BY A NURSE. A BRIEF CALL WAS CONDUCTED BETWEEN NTI AND THE CUSTOMER TO DISCUSS INITIAL DETAILS. THE REPORTER MENTIONED A NURSE MADE CONTACT WITH THE PROBE NEAR THE DAMAGE SITE AND IT WAS ACCIDENTALLY STEPPED ON. AS A RESULT, THE NURSE WAS SHOCKED. A FORMAL COMPLAINT WAS RECEIVED THROUGH THE CUSTOMERS COMPLAINT PORTAL TO OUR EMAIL ON (B)(6) 2026 WHICH READ THE FOLLOWING: RECORD ID: (B)(4) - EVENT DATE: (B)(6) 2026. EVENT DESCRIPTION: ECN EVENT. DESCRIPTION: PROBE WAS BEING REMOVE FROM SCOPE, PEDAL WAS STEPPED ON, PROBE SPARKED AND NURSE WAS ELECTROCUTED. WHAT TROUBLESHOOTING STEPS TOOK PLACE? WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? N/A. WHAT IS THE NEXT COURSE OF ACTION? N/A. PATIENT PRESENT AT TIME OF EVENT? YES. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS PATIENT OUTCOME: EXPECTED TO FULLY RECOVER TIME OF THE EVENT: DURING PROCEDURE INDICATE WHICH OF THE FOLLOWING OCCURRED AS A RESULT OF THE PROCEDURE: ORIGINAL METHOD/DEVICE USED DEVICE/PROCEDURE OUTCOME: PROCEDURE COMPLETED,ORIGINAL DEVICE USED PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT AS REPORTED DEVICE CODES: 2160: OUTPUT ENERGY INCORRECT AS REPORTED PATIENT CODES: 9087: ELECTRIC SHOCK COUNTRY OF EVENT: UNITED STATES. REGULATORY AFFAIRS ASKED THE FOLLOWING QUESTIONS WITH THE ANSWER RECEIVED LISTED BELOW. 1. WHAT PROCEDURE WAS BEING PERFORMED? ERCP 2. WHAT SPYSCOPE MODEL WAS IN USE? 3. WHERE WAS THE NURSE MAKING CONTACT WITH THE PROBE? AT THE DAMAGE SITE? AT THE HANDLE? WITH THE PROBE NEAR THE DAMAGE SITE. 4. WHAT LED TO THE FOOT PEDAL BEING PRESSED WHILE HANDLING THE PROBE? SOMEONE STEPPED ON PEDAL. WAS THE USER EXPERIENCED WITH THE EQUIPMENT? YES 5. THE COMPLAINT SPECIFIES THE NURSE WAS ELECTROCUTED WHICH IS DEFINED AS "TO KILL OR SEVERELY INJURE BY ELECTRIC SHOCK" VERSUS THE DEFINITION OF SHOCK IS "A SUDDEN, OFTEN PAINFUL, PHYSICAL REACTION CAUSED BY AN ELECTRIC CURRENT PASSING THROUGH THE BODY". CAN YOU CONFIRM IF THE NURSE WAS SHOCKED OR ELECTROCUTED? I CAN'T WHAT ARE THE SUSTAINED INJURIES BY THE NURSE? ARE THEY PERSISTENT/PROLONGED? THE NURSE IS CURRENTLY ON WORKMAN COMP LEAVE. 6. WAS THERE AN INDICATION THE PROBE WAS DAMAGED OR MALFUNCTIONING PRIOR TO ITS REMOVAL FROM THE SPYSCOPE? NO 7. HOW MANY SHOTS WERE FIRED ON THE PROBE BEFORE IT WAS REMOVED? UNKNOWN 8. IS THE PRODUCT BEING RETURNED FOR INVESTIGATION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347915 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL HYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES INC. 72-00322-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other