BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC

    MDR report key: 14851260 · Received June 29, 2022

    Report

    Report Number
    14851260
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    May 25, 2022
    Report Date
    October 7, 2022
    Manufacturer
    NORTHGATE TECHNOLOGIES, INC
    Product Code
    FFK
    UDI-DI
    00817183020448
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 29JUN2022, NORTHGATE TECHNOLOGIES INC RECEIVED THREE SEPARATE FDA 3500A REPORT FILING NOTIFICATIONS AGAINST 3 PROBES INVOLVED IN LIKELY THE SAME EVENT AS THEY WERE FROM THE SAME INSTITUTION, WITH SAME EVENT DATE AND SAME EVENT DESCRIPTION. WE INITIATED NC 22073 FOR THE INVESTIGATION AND REACHED OUT TO THE DISTRIBUTOR FOR INFORMATION PERTAINING TO COMPLAINTS FROM THE END USER AS NORTHGATE TECHNOLOGIES, INC WAS NOT AWARE OF THE MALFUNCTIONS PRIOR TO THE MEDWATCH REPORTING. ON 04JUL2022, THE DISTRIBUTOR REPORTED THE THREE COMPLAINTS TO NTI, AGAINST THE FDA 3500A REPORTS SUBMITTED BY THE END USER. THE DISTRIBUTOR INDICATED THERE WAS NO HEALTH CONSEQUENCES OR IMPACT TO PATIENT OUTCOME. ON 01SEP2022, THE DISTRIBUTOR HAS CLOSED THE COMPLAINT AFTER THREE FAILED ATTEMPTS REQUESTING FOR PRODUCT RETURN WITH THE END USER. THE DISTRIBUTOR INFORMED NTI TO CLOSE THE COMPLAINT AS NO PRODUCT RETURN. CAPA22073 WAS CLOSED WITH ASSESSMENT OF AVAILABLE INFORMATION AS A PHYSICAL EVALUATION OF THE PRODUCT WAS UNABLE TO BE PERFORMED. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED. THE DEVICE HISTORY RECORD FOR BSC15784 FROM JANUARY 2022 (MO 15784) WAS REVIEWED AND THE LOT PASSED ALL TESTING. THE NOR-DOC-DRA-0025 RISK ANALYSIS WAS REVIEWED. RISK ID 7.2.12(A) AND (B) REFERS TO DEGRADATION LEADING TO PARTICLE REMAINING IN THE BODY THAT MAY CAUSE BLOCKAGE POSSIBLY FROM THE TIP DETACHING, OR FIRING THE PROBE PAST USEFUL LIFE MAY CAUSE FIRING INSIDE THE POLYIMIDE SHEATH OR PROBE DETERIORATION CAUSING A PROCEDURE DELAY. PRODUCT LABELING INDICATES "SINGLE-USE ONLY" AND A LIFETIME EXPIRATION DATE. GENERATOR TRACKS PROBE LIFE AND ALERTS OPERATOR AS THE PROBE COMES CLOSE TO AND WHEN IT REACHES END OF LIFE. OPERATOR'S MANUAL WARNS TO REMOVE ALL PARTICLES. THE TIPS CAN BE REMOVED BY MINIMALLY INVASIVE MEANS OR THE TIPS WILL PASS THROUGH THE PATIENTS SYSTEM WITH NO HARM TO THE PATIENT. RISK ID 7.3.5 (D) REFERS TO ACCIDENTAL MECHANICAL DAMAGE THAT LEADS TO "NO SPARK DUE TO DAMAGED PROBE - PROCEDURE DELAYED". PER THE OPERATOR'S MANUAL ON PAGE 2 UNDER WARNINGS "TO AVOID PROCEDURAL DELAYS AND POSSIBLE INCOMPLETE STONE FRAGMENTATION, PLEASE HAVE TWO (2) OR MORE EHL PROBES AVAILABLE FOR EACH LITHOTRIPSY PROCEDURE." THE RISK OF DEATH OR SERIOUS INJURY FROM THE STATED ISSUE IS REMOTE. A FOLLOW UP REPORT WILL BE SUBMITTED IF FURTHER INFORMATION BECOMES AVAILABLE OR PRODUCT IS RETURNED BACK TO NTI FOR EVALUATION.

    Description of Event or Problem · 0

    PATIENT UNDERGOING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) CHOLANGIOSCOPY WITH EHL (ELECTROHYDRAULIC LITHOTRIPSY). FOUR PROBES WERE USED. PER ATTENDING PHYSICIAN: FIRST PROBE BROKE OUTSIDE OF PATIENT AFTER USE. SECOND PROBE USED UNTIL IT NO LONGER WORKED. THIRD PROBE TIP BROKE OFF.

    Description of Event or Problem · 0

    EVENT TITLE: --CONFIDENTIAL-- -------------------------------------- DESCRIBE THE EVENT OR PROBLEM: PATIENT UNDERGOING ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) CHOLANGIOSCOPY WITH EHL (ELECTROHYDRAULIC LITHOTRIPSY). FOUR PROBES WERE USED. PER ATTENDING PHYSICIAN: FIRST PROBE BROKE OUTSIDE OF PATIENT AFTER USE. SECOND PROBE USED UNTIL IT NO LONGER WORKED. THIRD PROBE TIP BROKE OFF. -------------------------------------- WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : ERCP -------------------------------------- WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2042895 AUTOLITH TCH 1.9FR PROBE, 375CM DS BSC INTRA-CORPOREAL ELECTROHYDRAULIC LITHOTRIPSY (IEHL) PROBE FFK NORTHGATE TECHNOLOGIES, INC 72-00322-0 BSC15784 00817183020448

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Female