Autolith Touch M005466800Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00817183020493), received between Feb 5, 2020 and Mar 28, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (9 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K130368); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 25, 2021Class IIOpen, Classified

   The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.

   Z-0333-2022 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 02/18/2025, NTI RECEIVED A COMPLAINT WHERE CUSTOMER REPORTED THAT "DURING PREPARATION IT WAS FOUND THAT THE EHL GENERATOR UNABLE TO GENERATE ANY PULSE". THE DEVICE WAS RECEIVED AT NTI ON 02/21/2025. DURING SERVICE EVALUATION OF THE DEVICE ON 03/03/2025, CUSTOMER COMPLAINT OF DEVICE NOT GENERATING PULSES WAS VERIFIED. IT WAS IDENTIFIED THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724994 ↗
• MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 05/17/2024 NTI RECEIVED A COMPLAINT WHERE CUSTOMER REPORTED THAT "SCREEN DOES NOT POWER ON". THE DEVICE WAS RECEIVED AT NTI ON 06/03/2024. DURING SERVICE EVALUATION OF THE DEVICE ON 06/12/2024, CUSTOMER COMPLAINT OF "SCREEN DOES NOT POWER ON" WAS NOT CONFIRMED. HOWEVER, IT WAS IDENTIFIED THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719971 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024 CUSTOMER REQUESTED AN RMA TO RETURN THE DEVICE TO NTI FOR EVALUATION, NO COMPLAINT NOR MALFUNCTION WAS REPORTED. DURING THE SERVICE EVALUATION ON 02/15/2024 IT WAS IDENTIFIED THAT THE INSULATED WIRES FROM THE HIGH VOLTAGE TRANSFORMER WERE DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE AMONG A NUMBER OF OTHER INSTANCES OF PHYSICAL DAMAGE NOTED TO THE EXTERIOR AND INTERIOR OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913551 ↗
• MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 02/02/2024 CUSTOMER REPORTED THAT " THE PROBE DOES NOT DELIVER ENERGY" THE DEVICE WAS RECEIVED AT NTI ON 2/06/2024. DURING THE SERVICE EVALUATION ON 02/15/2024 IT WAS IDENTIFIED THAT THE INSULATED WIRES FROM THE HIGH VOLTAGE TRANSFORMER WERE DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE AMONG A NUMBER OF OTHER INSTANCES OF PHYSICAL DAMAGE NOTED TO THE EXTERIOR AND INTERIOR OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18913546 ↗
• MalfunctionJul 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 04/03/2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED MALFUNCTION OF THE DEVICE THAT PREVENT THE DEVICES FROM BEING USED (THE DEVICE DID NOT FIRE). THE DEVICE WAS NOT RETURNED FOR EVALUATION UNTIL 6/14/2023. DURING THE SERVICE EVALUATION IT WAS IDENTIFIED THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17415433 ↗
• MalfunctionJan 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A DEVICE USED IN NON-CLINICAL DEMONSTRATIONS WITH NO RELATED COMPLAINTS WAS RETURNED FROM THE FIELD FOR PREVENTATIVE MAINTENANCE. DURING PREVENTATIVE MAINTENANCE IT IS NOTED THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER IS DISCONNECTED OR FOUND BROKEN FROM THE PRINTER CIRCUIT BOARD (LOOSE WIRE) WITHIN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244447 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PREVENTATIVE MAINTENANCE OF THE DEVICE AT NORTHGATE TECHNOLOGIES, INC, IT WAS IDENTIFIED IN SERVICE EVALUATION THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED (WIRE BROKEN) FROM THE HIGH VOLTAGE PCB WITHIN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654105 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE PREVENTATIVE MAINTENANCE OF THE DEVICE AT NORTHGATE TECHNOLOGIES, INC, IT WAS IDENTIFIED IN SERVICE EVALUATION THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED (WIRE BROKEN) FROM THE HIGH VOLTAGE PCB WITHIN THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961894 ↗
• MalfunctionSep 25, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED ISSUE ON AN AUTOLITH DEVICE ON (B)(6) 2021, "WE HAVE HAD SEVERAL ISSUES WITH OUR AUTOLITH INVOLVING FUSES BLOWING DURING PROCEDURES. THIS HAPPENED AGAIN EARLIER THIS WEEK. WE HAD BIOMED INVOLVED DURING THE PROCEDURE, WHICH SIGNIFICANTLY LENGTHENED THE PROCEDURE AND ANESTHESIA TIME. THE PATIENT ULTIMATELY SUFFERED A PROCEDURAL COMPLICATION THAT IS REQUIRING EXTENDED HOSPITALIZATION...."

  Patient problems: Insufficient Information

  MAUDE report 12530863 ↗
• MalfunctionSep 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE SERVICING OF A DEVICE FOR "AN UNKNOWN FAULT", IT WAS IDENTIFIED THAT THE HIGH VOLTAGE OUTPUT WIRE TO THE RESISTOR WAS DISCONNECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12456570 ↗
• MalfunctionAug 19, 2021Electrical /Electronic Property Problem; Arcing of Electrodes; Electrical /Electronic Property Problem; Arcing of Electrodes

  NORTHGATE TECHNOLOGIES, INC. (NTI) RECEIVED A DEVICE FOR EVALUATION WITH AN ALLEGED COMPLAINT OF "ONE OF THE PORTS IS ARCING ELECTRICAL...", THE COMPLAINT WAS CODED BY THE DISTRIBUTOR AS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. INITIAL EVALUATION OF THE DEVICE INDICATED, THE UNIT HAD SIGNS OF FLUID INVASION WITHIN THE FRONT PANEL AND THE UNIT WAS RECEIVED WITH THE FUSES REMOVED FROM THE POWER MODULE. THE NATURE OF THE FLUID CONTAMINATION COULD NOT BE DETERMINED. WHEN THE UNIT WAS POWERED ON WITH NEW FUSES, THE DISPLAY, SPARK GAPS WITHIN THE UNIT, AND HV TRIGGER BOARD LED WERE FLASHING INVOLUNTARILY WITHOUT CONNECTION TO ANY EXTERNAL SOURCES ATTACHED TO THE UNIT WHICH IS ABNORMAL (THE DEVICE IS DESIGNED SUCH THAT THE SPARK GAPS SHOULD ONLY ACTIVATE UPON ACTIVATION OF THE ATTACHED FOOT PEDAL ACCESSORY). THERE WAS NO ACTUAL ARCING OR FIRING NOTED WITHIN THE UNIT OR OUTSIDE THE UNIT HOWEVER GIVEN THAT THE SPARK GAPS WERE OBSERVED TO BE FLASHING THIS INDICATES THAT POWER COULD / WAS BEING TRANSFERRED TO THE BULKHEAD CONNECTOR WITHOUT ANY ACTIVATION. THE DEVICE IS DESIGNED WITH A BULKHEAD CONNECTOR WHICH IS CONNECTED TO A REUSABLE EXTENDER CABLE WHICH IS THEN CONNECTED TO DISPOSABLE BI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12345816 ↗
• MalfunctionFeb 5, 2020Break; Increase in Pressure; Unintended Electrical Shock; Break; Increase in Pressure; Unintended Electrical Shock

  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 RE

  Patient problems: Electric Shock; No Consequences Or Impact To Patient; Numbness

  MAUDE report 9671809 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K130368. One submission often covers many models, so check the product and lot details in each record.

• Z-1235-2022 · Apr 13, 2022 · Terminated
  AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
• Z-1883-2020 · Mar 10, 2020 · Terminated
  Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
• Z-1884-2020 · Mar 10, 2020 · Terminated
  AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.