Lithotripsy Probe 1.9FR 375cm DS M00546620Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00817183020448), received between Oct 20, 2017 and Jan 9, 2026 — classified as 1 death, 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

1 FDA recall record name this device's identifier.

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. Apr 13, 2022Class IITerminated

   Product labeled incorrectly.

   Z-1235-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 NTI RECIEVED A COMPLAINT WHERE THE CUSTOMER REPORTED "PHYSICIAN AIMED EHL AT THE STONE, IT BROKE THE STONE BUT CAME IN CONTACT WITH THE CYSTIC DUCT CAUSING A BLEED." THE DEVICE WAS NOT RETURNED TO NTI FOR FURTHER EVALUATION.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 24026974 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 09/24/2025 IT WAS REPORTED TO NORTHGATE TECHNOLOGIES INC. THAT "[THE] DR ADVISED THEY HAVE PERFORATED THE BILE DUCT - HE WAS UNSURE HOW AND SETTINGS ON EHL WERE 5 & LOW. HE DID NOT BLAME OUR DEVICES." A STENT WAS PLACED AND THE " PATIENT WILL NOW BE MONITORED CLOSELY TO SEE IF PERFORATION HEALS ON ITS OWN."

  Patient problems: Perforation

  MAUDE report 23357261 ↗
• InjuryAug 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO NORTHGATE TECHNOLOGIES, INC. ON 09JUN2023, "IT WAS REPORTED THAT: AT THE 105TH ANNUAL MEETING OF THE JAPAN GASTROINTESTINAL ENDOSCOPY SOCIETY (JGES), IT WAS REPORTED THAT 13 CASES OF CHOLANGITIS AND 2 CASES OF BILIARY HEMORRHAGE OCCURRED IN WHICH AUTOLITH EHL WAS USED, AND 2 CASES OF BILIARY HEMORRHAGE REQUIRED IVR DUE TO HEMORRHAGIC SHOCK. THE DETAILS ARE AS FOLLOWS: [SUBJECT]: PERCUTANEOUS TRANSHEPATIC CHOLANGIOSCOPY (PTCS)-ASSISTED ELECTROSHOCK WAVE LITHOTRIPSY (EHL) FOR INTRAHEPATIC LITHIASIS. [BACKGROUND]: IN THE RECENT YEARS, WITH THE ADVENT OF LARGE BALLOONS AND ORAL BILIARY CHOLANGIOSCOPY (POCS), IT HAS BECOME POSSIBLE TO TREAT MANY CASES OF COMMON BILE DUCT STONES, HOWEVER, INTRAHEPATIC STONES ARE STILL OFTEN DIFFICULT TO TREAT. EHL UNDER PTCS FOR INTRAHEPATIC STONES HAVE BEEN PERFORMED IN THE HOSPITAL AND THE RESULTS WERE REPORTED. [METHOD]: 66 PATIENTS WHO UNDERWENT EHL UNDER PTCS WERE INCLUDED AMONG THE 139 INTRAHEPATIC STONES TREATMENT PERFORMED IN THE DEPARTMENT FROM SEPTEMBER 1995 TO OCTOBER 2022. OLYMPUS BF260 (WITH THE TIP DIAMETER OF 4.9MM) WAS USED UNTIL 2017, AND OLYMPUS BF-XP290 (WITH THE TIP DIAMETER OF 3.1MM) WAS USED FROM 2018 ONWARDS. (1)

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock

  MAUDE report 17543274 ↗
• MalfunctionJul 20, 2023Unintended Electrical Shock; Unintended Electrical Shock

  ON 20JUN2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT " THE PHYSICIAN WAS PERFORMING EHL USING SPYGLASS DS AND AUTOLITH WITHOUT ANY PROBLEM. HOWEVER, AROUND 15-20 MIN INTO THE PROCEDURE, THE ANESTHESIOLOGIST COMPLAINED SAYING THAT SHE FELT AN ELECTRIC SHOCK AT THE PRECISE MOMENT WHEN AUTOLITH WAS SHOOT AND SHE TOUCHED THE PATIENT WITHOUT GLOVES. AFTER THAT THE AUTOLITH PROBE WAS WITHDRAWN AND THE SPYSCOPE STOPPED WORKING."

  Patient problems: Electric Shock

  MAUDE report 17368180 ↗
• DeathMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 24APR2023 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC, "PER CNF, IT WAS REPORTED THAT: EHL WAS PERFORMED USING AN OLYMPUS BILIARY SPECULUM. THE PROCEDURE ITSELF WAS SUCCESSFUL, BUT THE PATIENT'S CONDITION CHANGED SUDDENLY AND HE DIED LATER THAT DAY. THE PATIENT'S CONDITION CHANGED SUDDENLY DUE TO BLEEDING FROM THE LIVER OBLITERATION THAT OCCURRED THE DAY AFTER THE PROCEDURE." "AS REPORTED DEVICE CODES: 2099: NO KNOWN DEVICE PROBLEM" "EVENT OCCURRED (B)(6) 2023, PROCEDURE OCCURRED (B)(6) 2023". ADDITIONAL QUESTIONS WERE FOLLOWED UP WITH THE DISTRIBUTOR. ON 15MAY2023, THE DISTRIBUTOR PROVIDED ADDITIONAL INFORMATION THAT THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK AND THAT THE PATIENT WAS A POST-LIVER TRANSPLANT PATIENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypovolemic Shock

  MAUDE report 16997494 ↗
• InjurySep 29, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  ON (B)(6) 2022 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC, "PER CNF, IT WAS REPORTED THAT: SPYDS+EHL WAS PERFORMED ON A CASE OF ACCUMULATED STONES OF COMMON BILE DUCT STONES, BUT AFTER THE SURGERY BILE DUCT PERFORATION WAS SUSPECTED, AND THE NEXT DAY CT SHOWED THE DIAGNOSIS WITH A BILE DUCT PERFORATION, SO AN EMERGENCY SURGERY WAS PERFORMED PROMPTLY. IT WAS THOUGHT THAT THE CAUSE OF THE PERFORATION WAS CAUSED BY THE EHL PROBE COMING INTO CONTACT WITH THE BILE DUCT WALL SEVERAL TIMES. FORTUNATELY, THE PATIENT WAS NOT IN A SEVERE SITUATION AND THE PATIENT RECOVERED. IT WAS SAID THAT, LOOKING AT SYSTEMATIC REVIEWS OVERSEAS, PERFORATION OCCURS ABOUT 1-10%, SO I FELT THAT CARE SHOULD BE TAKEN IN CASES WHERE BILE DUCTS ARE DILATED BY COMMON BILE DUCT PILED STONES, CASES WHERE IT IS IMPACTED ON THE BILE DUCTS, AND CASES WHERE THE BILE DUCTS ARE IN A VERTICAL POSITION WITH RESPECT TO EHL PROBES. PROCEDURE OUTCOME: THE PROCEDURE WAS COMPLETED USING THIS DEVICE. SCOPE USED? YES GUIDEWIRE USED? YES GENERATOR/CONTROLLER USED? YES OTHER USED? UNKNOWN","ENDOSCOPIC PAPILLOTOMY 3. ACCOMPANIED BY BILIARY SCOPIC LITHOTRIPSIS". ADDITIONAL QUESTIO

  Patient problems: Perforation

  MAUDE report 15504392 ↗
• MalfunctionJun 29, 2022No Apparent Adverse Event; Insufficient Device Problem Information; Break; No Apparent Adverse Event; Insufficient Device Problem Information

  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.

  Patient problems: Insufficient Information

  MAUDE report 14851286 ↗
• MalfunctionJun 29, 2022No Apparent Adverse Event; Insufficient Device Problem Information; Break; Therapeutic or Diagnostic Output Failure; No Apparent Adverse Event; Insufficient Device Problem Information

  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. PROBES #2 & #3 ARE FROM THE SAME LOT #.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851262 ↗
• MalfunctionJun 29, 2022No Apparent Adverse Event; Insufficient Device Problem Information; Break; Therapeutic or Diagnostic Output Failure; No Apparent Adverse Event; Insufficient Device Problem Information

  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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851260 ↗
• InjuryJun 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION." IT WAS REPORTED THAT: THE SUBJECT UNDERWENT THE STUDY PROCEDURE ON (B)(6) 2022. SPYGLASS DISCOVER DIGITAL CATHETER: (B)(4). NO ADDITIONAL SPYGLASS CATHETER WAS USED IN THE PROCEDURE SPYGLASS DISCOVER CATHETER WAS ADVANCED TO TARGET; TARGET LESION OR STONES WERE VISUALIZED AND A GUIDEWIRE WAS USED TO ADVANCE THE SPYGLASS DISCOVER DURING PTCS. DIAMETER OF LAST CATHETER USED PRIOR TO ADVANCING THE SPYGLASS DISCOVER (11 FR) PTCS PROCEDURAL MANEUVERS: - CLEARANCE OF BILIARY STONE(S)/SLUDGE, WITH LITHOTRIPSY: MECHANICAL, ELECTROHYDRAULIC OR LASER: ATTEMPTED AND COMPLETED (BSC DEVICE); INTRADUCTAL DRAIN REMAINED IN PLACE FOR PATIENT SAFETY (10FR) NO, INTRAPERITONEAL DRAIN WAS PLACED AT THE END OF THE PROCEDURE. THE SUBJECT EXPERIENCED THE FOLLOWING EVENTS: ONSET DATE: (B)(6) 2022. ONSET LATENCY: 1 DAYS; EVENT: SEPSIS (EVENT ID 1) SEVERITY: MODERATE; SERIOUS CRITERIA: HOSPITALIZED; ACTION TAKEN: HOSPITAL, DRUG THERAPY (ANTIBIOTICS - TAZOCIN) ; OUTCOME: ONGOING; DEVICE RELATIONSHIP: PROBABLE (SPYGLASS DISCOVER DIGITAL CATHETER) PANCREATICOBILIARY DUCTAL ACCESS POR

  Patient problems: Sepsis

  MAUDE report 14685262 ↗
• MalfunctionMay 20, 2022Sparking; Sparking

  ON (B)(6) 2022 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT," THE LITHOTYPING PROBE IS CONNECTED TO THE EQUIPMENT, IT IS PASSED TO THE SPECIALIST TO START THE PROCEDURE AND IT IS SEEN THAT IT IS NOT FRACTURING THE STONES, THE DOCTOR INDICATES THAT HE FEELS SOMETHING THAT IS NOT RIGHT WITH THE PROBE, 3 MORE SHOTS WERE MADE AND THE PROBE MAKES A KIND OF SHORT IN THE DISTAL PART, SPARKS CAME OUT OF THE PART WHERE THE COATING IS LOCATED, IMMEDIATELY THE PROCEDURE WAS STOPPED AND THE PROBE WAS CHANGED." THE HEALTH PROFESSIONAL COMPLETED THE PROCEDURE BY USING A DIFFERENT DEVICE OF THE SAME MODEL TYPE. NO ALLEGATIONS OF PATIENT OR USER INJURY WAS REPORTED FROM THE EVENT. ON (B)(6) 2022 AND (B)(6) 2022, NTI SEND FOLLOW UP QUESTIONS TO THE CUSTOMER TO UNDERSTAND IF THERE WAS A DEVICE MALFUNCTION. WITH THE AVAILABLE INFORMATION FROM THE CUSTOMER THE PROBE FIRED FROM THE DISTAL END AND IS NOT DEEMED AS A MALFUNCTION OF THE DEVICE TO BE REPORTABLE ON (B)(6) 2022. THE SUSPECT DEVICE WAS RETURNED ON (B)(6) 2022 AND IN EVALUATION THE DEVICE APPEARED TO HAVE MALFUNCTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14458838 ↗
• MalfunctionApr 8, 2022Sparking; Sparking

  ON 11MAR2022 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION,"...INITIALLY, THE PROBE WAS SET TO MEDIUM POWER, 10 SHOTS, AND WHEN THE EHL PEDAL WAS DEPRESSED, NOTHING HAPPENED TO THE STONE THAT WAS LODGED BETWEEN THE CYSTIC DUCT AND THE BILE DUCT. THE PHYSICIAN REQUESTED THE POWER BE TURNED UP TO HIGH, MAXIMUM SHOTS, AND SUDDENLY THE TECHNICIAN HOLDING THE PROBE EXPERIENCED A SHOCK TO HER HAND THAT WAS VISIBLE (SPARK) AND AUDIBLE (LOUD CRACK) TO THE ROOM. THE TECHNICIAN CLAIMS SHE IS EXPERIENCING RESIDUAL PAIN, EVEN AN HOUR POST PROCEDURE (AT THE TIME OF THIS WRITTEN COMPLAINT). THEY REMOVED THE PROBE AND USED ANOTHER OF THE SAME. THE NEW PROBE WORKED AND THE PROCEDURE WAS COMPLETED. THE TECHNICIAN IS OKAY, BUT SHE CLAIMS SHE HAS A BURNING PAIN IN HER HAND PREVENTING HER FROM WORKING. THE HOSPITAL IS FILING AN INCIDENT REPORT AND WANTS TO KNOW THE RESULTS OF OUR FINDINGS ON THE PROBE...". BASED ON ADDITIONAL QUESTIONS ASKED FROM THE MANUFACTURER THE INITIAL REPORTER INDICATED ON 18MAR2022 THAT NO ADDITIONAL THERAPY OR TREATMENT WAS OFFERED TO THE TECHNICIAN AND THAT THEY WERE "ABLE TO REST WHILE HER HAND RECOVERED.", "SH

  Patient problems: Electric Shock

  MAUDE report 14056873 ↗
• InjuryMar 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 21FEB2022, NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION "...AFTER LESS THAN 24 HOURS THE SUBJECT HAD AN EPISODE OF CHOLANGITIS. THE ADVERSE EVENT IS SERIOUS SINCE THE OUTCOME WILL RESULT IN PROLONGED HOSPITALIZATION. THE RELATIONSHIP WITH OUR PROCEDURE IS PROBABLE. A CHOLANGIOGRAPHY WAS PERFORMED ON (B)(6) 2022, BUT NO RESIDUAL LITHIASIS WAS OBSERVED. THE BILIARY DRAINAGE WAS REPLACED. THE SUBJECT WAS TREATED WITH ANTIBIOTIC THERAPY AND IS FINE". THERE WAS NO ALLEGED DEVICE MALFUNCTION DURING THE EHL PROCEDURE.

  Patient problems: Bacterial Infection; Hepatitis

  MAUDE report 13793864 ↗
• InjuryMar 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 21FEB2022, NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION "...AFTER LESS THAN 24 HOURS THE SUBJECT HAD AN EPISODE OF CHOLANGITIS. THE ADVERSE EVENT IS SERIOUS SINCE THE OUTCOME WILL RESULT IN PROLONGED HOSPITALIZATION. THE RELATIONSHIP WITH OUR PROCEDURE IS PROBABLE. A CHOLANGIOGRAPHY WAS PERFORMED ON (B)(6) 2022, BUT NO RESIDUAL LITHIASIS WAS OBSERVED. THE BILIARY DRAINAGE WAS REPLACED. THE SUBJECT WAS TREATED WITH ANTIBIOTIC THERAPY AND IS FINE". THERE WAS NO ALLEGED DEVICE MALFUNCTION DURING THE EHL PROCEDURE.

  Patient problems: Bacterial Infection; Hepatitis

  MAUDE report 13793829 ↗
• MalfunctionDec 23, 2021Separation Problem; Separation Problem

  ON (B)(6) 2021 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEGED EVENT FROM DISTRIBUTOR BOSTON SCIENTIFIC CORPORATION," NO PATIENT COMPLICATIONS. WHILE FIRING THE PROBE THE DISTAL TIP BROCK OFF. (DR. (B)(6)) REMOVED THE PROBE BUT WAS UNABLE TO RETRIEVE THE BROKEN PIECE. HE DECIDED TO TRY A NEW PROBE TO COMPLETE THE FRACTURING OF THE PANCREATIC STONE. WHAT TROUBLESHOOTING STEPS TOOK PLACE? THEY NEEDED TO REPLACE THE PROBE. WHAT TROUBLESHOOTING STEPS, IF ANY, RESOLVED THE ISSUE? WHAT IS THE NEXT COURSE OF ACTION? REPLACE DEFECTIVE DEVISE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078044 ↗
• MalfunctionNov 12, 2021Sparking; Sparking

  ON 8/23/2021 NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED EVENT FROM THE DISTRIBUTOR (B)(4), "THE PROBE BURST". NO ALLEGATION OF AN ADVERSE EVENT OR PATIENT COMPLICATION WAS NOTED IN THE COMPLAINT NOTIFICATION FROM THE DISTRIBUTOR. DESPITE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION ON THE ALLEGED ISSUE, SERIAL / LOT TRACEABILITY, AND REQUEST TO SENT IN THE ALLEGED DEVICE FOR FURTHER INVESTIGATION, NO RESPONSES WERE RECEIVED BY NTI. ON SEPTEMBER 28, 2021 THE CUSTOMER INFORMED THE REPORTED DEVICE WAS DISPOSED OF AND NO FURTHER INFORMATION WAS AVAILABLE FOR FURTHER INVESTIGATION. ON 10/14/2021 THE ALLEGED DEVICE WAS NOTIFIED AS BEING RETURNED FOR FURTHER EVALUATION. THIS DEVICE WAS INVESTIGATED UNDER CAPA (B)(4) AFTER THE INITIAL DEVICE EVALUATION IDENTIFIED THAT WHEN ACTIVATED THE PROBE DID NOT SPARK AT THE TIP (AS DESIGNED) AND THAT THE DEVICE EXHIBITED SPARKING AT THE CONNECTION OF THE CONNECTOR AND THE HEAT SHRINK INSTEAD. IT WAS OBSERVED THAT THE DEVICE HAD A SHARP CUT ABOUT 1/4 INCH LONG WHICH IS WHERE THE POINT OF SPARKING WAS OBSERVED. IT IS UNCLEAR IF THE SPARKING IS WHAT THE COMPLAINANT WAS REPORTING WHEN INDICATING "BURST". IT IS ALSO UNCLEAR HOW THE CUT IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805651 ↗
• MalfunctionSep 15, 2021Separation Problem; Separation Problem

  ON 16AUG2021, NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF THE ALLEDGED EVENT, "...IT WAS REPORTED THAT: DR [REDACTED] THEN HAD TO USE A BASKET TO REMOVE THE BROKEN TIP FROM THE PANCREATIC DUCT. AS FAR AS WE ARE AWARE AT THE PRESENT MOMENT, THE PATIENT DID NOT INCUR ANY INJURY. BUT, THERE WAS POTENTIAL FOR INJURY TO THE PATIENT FROM THE PROBE TIP BEING COMPLETELY BROKEN OFF (FORTUNATELY DR NOTICED SOMETHING "BLACK FLOATING" AROUND IN THE PATIENTS PANCREATIC DUCT AND WAS SUCCESSFULLY ABLE TO REMOVE IT)..."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475857 ↗
• MalfunctionApr 1, 2021Sparking; Sparking

  NORTHGATE TECHNOLOGIES WAS MADE AWARE OF THE FOLLOWING EVENT " THE SPYGLASS WAS PASSED INTO THE PATIENTS BILE DUCT AND THE STONE WAS VISUALIZED THROUGH SPYGLASS. THE EHL PROBE WAS OPENED AND PASSED DOWN THE WORKING CHANNEL OF THE SPYSCOPE. IT WAS CONNECTED TO THE GENERATOR PROPERLY. ONCE THE PHYSICIAN WENT TO STEP ON THE GENERATOR PEDAL THE PROBE SPARKED AND ZAPPED NEAR THE CONNECTION OF THE PROBE END TO THE GENERATOR AS THE NURSE WAS HOLDING IT. IT WAS LATER COMMUNICATED TO ME THAT THE NURSE HAD GOTTEN SOMETHING IN [REDACTED THE] EYE AND THE LAB WAS SENDING [REDACTED NURSE] TO GET [REDACTED THEIR] EYES CHECKED. I WAS LATER TOLD THEY FOUND 3 BURN SPOTS ON [REDACTED NURSE'S] EYE AND THEY ARE SENDING [REDACTED NURSE] TO THE DOCTOR." AFTER FURTHER FOLLOW UP WITH THE INITIAL REPORTER IT WAS INDICATED THAT THE NURSE "WENT TO SEE A DOCTOR [REDACTED] AS A PRECAUTIONARY MEASURE. THEY INDICATED THAT [REDACTED NURSE] HAD 3 BURN SPOTS ON [REDACTED THEIR] EYE. WHILE [REDACTED NURSE] DOES NOT HAVE ANY SERIOUS DISCOMFORT AOR ANY VISION ISSUES [REDACTED NURSE] WANTED IT REPORTED AND WANTS TO MAKE SURE WE REPORTED IT."

  Patient problems: Eye Burn

  MAUDE report 11605803 ↗
• MalfunctionOct 20, 2017Charred; Charred

  ON SEPTEMBER 21, 2017, NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN EVENT IN WHICH IT WAS ALLEGED THAT DURING A PROCEDURE, "AUTOLITH FIBER FAILED TO WORK AFTER SEVERAL MINUTES OF TRYING TO BREAK UP A STONE ON MEDIUM POWER. BURNING SMELL NOTICED DURING THE CASE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6965725 ↗

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-0333-2022 · Oct 25, 2021 · Open, Classified
  Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL p
• 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.