BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLITH TOUCH

    MDR report key: 9671809 · Received February 5, 2020

    Report

    Report Number
    0001450997-2020-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2020
    Date of Event
    November 16, 2019
    Report Date
    February 4, 2020
    Manufacturer
    NORTHGATE TECHNOLOGIES INC.
    Product Code
    FFK
    UDI-DI
    00817183020493
    PMA / PMN Number
    K130368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS INVESTIGATED VIA CAPA 20003. BASED ON THE DESCRIPTION OF THE COMPLAINT, IT IS APPARENT THAT RESTRICTION OF FLOW TO THE PNEUMOPERITONEUM WAS OCCURRING DUE TO ADHESION OF THE TROCAR TO THE SCAR TISSUE. WHEN A RESTRICTION OCCURS AND THEN IS CLEARED, OVER PRESSURE WILL SOMETIMES HAPPEN, ESPECIALLY AT HIGHER FLOW RATE. THE DEVICE HAS BUILT IN MECHANISMS TO RELIEVE THE OVER-PRESSURE CONDITION VIA SOFTWARE CONTROLLED AND MECHANICALLY CONTROLLED PRESSURE RELIEF VALVES. AFTER THE INVESTIGATION AND SINCE NO ISSUES WERE FOUND DURING THE EVALUATION AND FQC TESTING, AND THE DEVICE IS FUNCTIONING NORMAL AND AS DESIGNED, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE LITHOTRIPTER, NTI PART NUMBER 72-00275-0; SERIAL NUMBER (B)(4) ARRIVED AT NTI ON 1/9/20 FROM AMERICAN DISTRIBUTOR BOSTON SCIENTIFIC, INC.. THE DEVICE AND COMPLAINT WERE EVALUATED UNDER NTI CAPA (B)(4). THIS IS BEING REPORTED AS A MALFUNCTION AS THE ALLEGED "ELECTRICAL SHOCK" DID NOT CLASSIFY AS A SERIOUS INJURY PER 21 CFR 803.3. (I.E., WAS NOT (1) "IS LIFE-THREATENING, (2) RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR (3) NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. PERMANENT MEANS IRREVERSIBLE IMPAIRMENT OR DAMAGE TO A BODY STRUCTURE OR FUNCTION, EXCLUDING TRIVIAL IMPAIRMENT OR DAMAGE.") UPON POWER UP, THE UNIT IMMEDIATELY WENT INTO FAULT CODE #10 WHICH IS LOSS OF CALIBRATION. AS STATED IN THE COMPLAINT, FAULT CODE #11 OCCURRED DURING THE PROCEDURE WHICH IS A "FEEDBACK FAULT - THIS FAULT IS SET WHEN THE MACHINE IS NOT ABLE TO TRACK INDIVIDUAL SHOTS". THIS FAULT CODE IS RESETTABLE BY POWER CYCLING THE DEVICE. THE DEVICE WAS TESTED THROUGH TWO HIPOT TESTS. THE 60 SECOND 10KV, WHICH HAS THE COVER ON, TEST PASSED. THE 10 SECOND 1.5KV TEST, WHICH HAS THE COVER OFF, PASSED AS WELL BUT IT WAS NOTED THAT ONE OF THE WIRES ON THE HV TRIGGER BOARD WAS DETACHED FROM THE BOARD. THE INSIDE OF THE COVER ALSO HAS SOME BURN MARKS (ROUGHLY 12 "CONTACT" POINTS) IN THE VICINITY OF THE BROKEN WIRE. BOTH OBSERVATIONS SUGGESTED THAT DURING THE OPERATION OF THE DEVICE THE HIGH VOLTAGE PULSES WERE INADVERTENTLY DELIVERED THROUGH THE BROKEN CABLE TO THE CHASSIS COVER RESULTING IN SPARKS BEING GENERATED. THE ROOT CAUSE FOR THE ALLEGED ELECTRICAL SHOCK HAS BEEN IDENTIFIED AS A BROKEN WIRE ON THE SECONDARY SIDE OF THE HV OUTPUT TRANSFORMER COMPROMISING THE ISOLATION PROTECTION. IT IS UNCLEAR HOW THE WIRE DETACHED FROM THE PCB. IT SHOULD BE NOTED THAT THE ORIGINAL COMPLAINT STATED THAT AT THE BEGINNING OF THE PROCEDURE, THE DEVICE WAS OPERATING NORMALLY. THIS IS THE FIRST INSTANCE OF A WIRE ON THE SECONDARY SIDE OF THE HV OUTPUT TRANSFORMER BREAKING AND COMPROMISING THE ISOLATION PROTECTION. A DEVICE HISTORY RECORD REVIEW (DHR) WAS CONDUCTED FOR THE DEVICE UNDER COMPLAINT 19488. THE DEVICE HISTORY RECORD FOR 22389CCB FROM MARCH OF 2018 (MANUFACTURING ORDER (B)(4)) WAS REVIEWED AND THE DEVICE PASSED ALL TESTING. DURING INITIAL PRODUCTION A DEFECT WAS FOUND IN A PIXEL OF THE LCD DISPLAY, THE LCD DISPLAY WAS REPLACED. THE DEVICE PASSED ALL INSPECTIONS AND TESTING AFTER THE REWORK. THE DEVICE HAS NOT BEEN RETURNED TO NTI FOR REPAIR / EVALUATION PREVIOUSLY. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED TO NTI FOR THIS DEVICE. ANY ADDITIONAL FINDINGS WILL BE UPDATED VIA A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON 11/19/19 NTI WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT "IT WAS REPORTED THAT DURING AN ERCP THE PHYSICIAN STARTED USING THE EHL TO BREAK STONES, AND EVERYTHING WAS GOING LIKE ITS USED TO. AT A MOMENT, WHILE HE WAS BREAKING STONE, A NURSE WHO WERE INVOLVED IN THE CASE TO MANAGE PATIENT, RECEIVED WHAT SHE DESCRIBES AS AN ELECTRIC SHOCK. HER LEFT ARM WAS REALLY NEAR THE BELLY OF THE PATIENT. JUST AT THE LEVEL OF THE LIVER, WHERE THE PHYSICIAN WAS BREAKING STONES. SHE SAT DOWN A BIT, A LITTLE BIT CONCERNED BUT WITHOUT ANY PAIN OF FEELING SICK. SHE FELT A KIND OF NUMBNESS IN HER LEFT HAND. THIS SENSATION REMAINED FOR ABOUT AN HOUR ACCORDING TO HIS WORDS. SHE WAS ABLE TO CONTINUE WORKING IN THE CASE, CLOSELY TO THE PATIENT, WHILE THE PHYSICIAN WAS FINISHING TO BREAK THE STONE. AT A MOMENT, THE AUTOLITH TOUCH GENERATOR STOP WORKING, AND THIS MESSAGE BEEN DISPLAYED ON THE AUTOLITH KEYBOARD: REPORT FAULT CODE # 11 SERVICE UNIT ... SO AT THIS MOMENT, THE PHYSICIAN STOP USING THE EHL IN THIS CASE, AND COMPLETED THE CASE WITH REGULAR DEVICES LIKE BALLOON, BASKET, ETC. ALL THE STONES WERE BROKE, AND CBD WAS CLEARED AND PROCEDURE SUCCESSFUL ENDED FOR THE PATIENT. SO, AFTER THIS CASE, I RECEIVE A CALL FROM AIC ENDO, MENTIONING SHE RECEIVED THE COMPLAINT INTERNALLY FROM THE NURSE, REGARDING THE EVENT IMPLICATING OUR AUTOLITH TOUCH, AND EXPLAINING SHE RECEIVED AN ELECTRIC SHOCK. SHE WAS OK, WITH NO PAIN OR ANY OTHER ADVERSE REACTIONS. NO ECG BEEN DONE ON HER. THEY WERE CONCERNED ABOUT THE PATIENT, ON IF THEY NEED TO ADDRESS THE SITUATION WITH PATIENT FOR ANY INJURY. ON THE CLINICAL SIDE, THE PATIENT WASN'T DEMONSTRATING ANY INJURY SYMPTOMS, EITHER VISUALLY IN THE BILE DUCT OR PHYSICALLY AFTER THE CASE. SHE WOKE UP LIKE NORMAL, AND DIDN'T FEEL ANY IRREGULAR PAIN. A LITTLE BIT OF BLOOD WAS VISIBLE DURING THE STONE EXTRACTIONS, BUT THE PHYSICIAN WASN'T CONCERNED ABOUT IT..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136242 AUTOLITH TOUCH LITHOTRIPTER FFK NORTHGATE TECHNOLOGIES INC. 72-00275-0 00817183020493

    Patients

    Seq Age Sex Outcome Treatment
    1