AUTOLITH TOUCH

Additional Manufacturer Narrative

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, NOR-SPEC-6100-1230 REV C, "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. 22140LBB (UPDATED TO RLBB AFTER BEING RETURNED ONCE PREVIOUSLY) WAS MANUFACTURED UNDER MO 12832 IN DECEMBER 2017. THE DEVICE PASSED ALL TESTING AND NOTHING OUT OF THE ORDINARY WAS NOTED. THE DEVICE WAS RETURNED ONCE PREVIOUSLY DUE TO AN ISSUE TURNING ON WHICH WAS REPAIRED IN OCTOBER OF 2020. THERE IS NO DIRECT INDICATION THE DEVICE WAS THE ROOT CAUSE LEADING TO USER INJURY. USE OF A DAMAGED/ DEFECTIVE PROBE COULD RESULT IN AN INJURY TO THE PATIENT OR THE USER. THE PRODUCT RISK FILE, NOR-DOC-DRA-0025 REV T, IDENTIFIES RISK OF SHOCK FROM CONTACT WITH THE PROBE OR EXTENDER CABLE. A CLINICAL EVALUATION, NOR-DOC-CER-0002, 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

ON FEBRUARY 15TH, 2026, NORTHGATE TECHNOLOGIES INC. WAS INFORMED OF AN ALLEGED EVENT FROM BOSTON SCIENTIFIC CORPORATION READING " RECORD ID: (B)(4) - 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 (B)(6) 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. 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 ED34-I10T2 DEVICE/PROCEDURE OUTCOME: ORIGINAL DEVICE USED,PROCEDURE 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".