ECHELON ENDOPATH EC60Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10705036001690), received between Nov 22, 2017 and Jul 18, 2025 — classified as 9 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (18 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  TITLE: COMPARISON OF SHORT-TERM EFFICACY OF MINIMALLY INVASIVE VERSUS OPEN ESOPHAGOGASTRIC JUNCTION ADENOCARCINOMA AUTHORS: REN TINGKAI, YANG XUEFENG, DONG YANJUN, ZHENG XIANJIE, ZHANG SHUANGLIN CITATION: JOURNAL OF HENAN UNIVERSITY (MEDICAL SCIENCE) DOI: DOI: 10.15991/J.CNKI .41- 1361/R.2020.03.009. THE AIM OF THIS STUDY IS TO COMPARE THE EFFECT OF MINIMALLY INVASIVE MODIFIED IVOR-LEWIS OPERATION AND LEFT THORACOTOMY ON ADENOCARCINOMA OF ESOPHAGOGASTRIC JUNCTION. BETWEEN JUNE 2016 TO JULY 2018, A TOTAL OF F 56 PATIENTS WITH AEG WHO UNDERWENT SURGERY IN THE FIRST AFFILIATED HOSPITAL OF HENAN UNIVERSITY. THERE WERE 33 MALES AND 23 FEMALES; THE AGE OF THE WHOLE GROUP WAS 53 YEARS; THERE WERE 12 CASES OF SIEWERT TYPE I, 38 CASES OF TYPE II, AND 6 CASES OF TYPE III. IN CONTROL GROUP : IN THE RIGHT LATERAL DECUBITUS POSITION, THE CHEST WAS ENTERED THROUGH A POSTEROLATERAL INCISION IN THE LEFT 6TH OR 7TH INTERCOSTAL SPACE, UNILATERAL LUNG BREATHING WAS PERFORMED, THE ESOPHAGUS AND AORTA WERE FREED, THE UPPER MEDIASTINAL, PARAESOPHAGEAL, AND SUBCARINAL LYMPH NODES WERE DISSECTED, THE DIAPHRAGM WAS OPENED, AND THE ESOPHAGUS AND GASTRIC TISSUES WERE CUT 5 CM FROM THE UPPER AND LOWER EDGES O

  Patient problems: Failure to Anastomose

  MAUDE report 22544179 ↗
• MalfunctionDec 4, 2023Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED AND NOTED THE METAL PART OF CARTRIDGE WAS DEFORMED. CHANGED TO ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256512 ↗
• MalfunctionFeb 17, 2023Failure to Cut; Insufficient Device Problem Information; Failure to Cut; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE KNIFE DIDN'T CUT TO THE END. AFTER TRIGGERING A SECOND TIME, THE DEVICE WAS JAMMED. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397007 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: RESECTION OF THE GASTRIC SUBMUCOSAL TUMOR (G-SMT) ORIGINATING FROM THE MUSCULARIS PROPRIA LAYER: COMPARISON OF EFFICACY, PATIENTS¿ TOLERABILITY, AND CLINICAL OUTCOMES BETWEEN ENDOSCOPIC FULL-THICKNESS RESECTION AND SURGICAL RESECTION AUTHORS: SHA LIU, XINXIN ZHOU, YONGXING YAO, KEDA SHI, MOSANG YU, FENG JI CITATION: SURGICAL ENDOSCOPY (2020); 34: 4053¿4064. DOI: HTTPS://DOI.ORG/10.1007/S00464-019-07311-X THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND CLINICAL OUTCOMES OF EFTR AND SURGICAL INTERVENTION FOR THE MANAGEMENT OF MUSCULARIS PROPRIA (MP)-DERIVED G-SMTS. BETWEEN SEPTEMBER 2011 AND MAY 2019, A TOTAL OF 62 PATIENTS (25 MALE AND 37 FEMALE; MEAN AGE OF 57.35 ± 9.88 YEARS) WITH PRIMARY MP-DERIVED G-SMTS WERE ENROLLED INTO THE ENDOSCOPIC FULL-THICKNESS RESECTION (EFTR) GROUP (STUDY GROUP). FOR COMPARATIVE ASSESSMENT, A GROUP OF 62 PATIENTS (24 MALE AND 38 FEMALE; MEAN AGE OF 58.92 ± 9.66 YEARS) WITH G-SMTS TREATED BY SURGERY IN THE SAME PERIOD WAS MATCHED FOR PATIENT BASELINE CHARACTERISTICS, TUMOR CLINICOPATHOLOGICAL FEATURES AS WELL AS THE YEAR PART OF THE PROCEDURE DATE. IN THE SURGICAL RESECTION GRO

  Patient problems: Abdominal Distention; Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Nausea; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256610 ↗
• InjuryJul 2, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE THAT IT WAS MENTIONED THAT COMPLICATIONS OCCURRED IN 5 CASES OF PULMONARY INFECTION, 3 CASES OF ARRHYTHMIA, 1 CASE OF ANASTOMOTIC LEAKAGE AND 1 CASE OF RECURRENT LARYNGEAL NERVE INJURY AFTER USING JOHNSON & JOHNSON ULTRASONIC SCALPEL.

  Patient problems: Arrhythmia; Failure to Anastomose; Respiratory Tract Infection

  MAUDE report 12106546 ↗
• MalfunctionMay 10, 2021Mechanical Problem; Difficult to Open or Close; Mechanical Problem; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A THORACOSCOPY LOBECTOMY SURGERY, THE SURGEON NOTED AFTER FIRING, COULD NOT OPEN THE JAW AND TRY MANY TIMES TO OPEN THE JAW. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797648 ↗
• MalfunctionNov 26, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE OPEN COLON SURGERY , WHEN SEVERING TRANSVERSE COLON TISSUE ON THE 1ST FIRING, AFTER FIRED, NOTED STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10909285 ↗
• MalfunctionApr 27, 2020Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RADICAL RESECTION OF HILAR CHOLANGIOCARCINOMA, BEFORE USING THE DEVICE ON THE PATIENT, THE SURGEON INSTALLED THE RELOAD AND NOTED IT WAS DIFFICULT TO OPEN JAW AFTER CLOSING IT. THEN THE SURGEON CHANGED ANOTHER THREE RELOADS (ONE ECR60B, TWO ECR60WS), BUT IT WAS STILL HARD TO OPEN THE JAW. ANOTHER GUN WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10000867 ↗
• MalfunctionJan 6, 2020Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRECTOMY SURGERY, THE DEVICE WOULD NOT FIRE WHEN SEVERING DUODENUM TISSUE ON THE 1ST FIRING. CHANGED TO A NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9555266 ↗
• MalfunctionNov 27, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LEFT HEMIHEPATECTOMY , WHEN SEVERING THE VESSEL, COULD NOT FIRE. CHNAGED ANOTHER TWO RELOADS, STILL COULD NOT FIRE. CHANGED ANOTHER GUN AND RELOAD, COULD NOT FIRE. CHANGED ANOTHER RELOAD, COULD NOT FIRE. CHANGED EC45 TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9384795 ↗
• MalfunctionNov 15, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE THORACOSCOPIC LOBECTOMY SURGERY, COULD NOT FIRE ON THE THIRD FIRING. CHANGED A NEW RELOAD TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328109 ↗
• MalfunctionNov 1, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, COULD NOT FIRE WHEN SEVERING TISSUE ON THE 2ND FIRING. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9266678 ↗
• MalfunctionSep 30, 2019Mechanical Jam

  IT WAS REPORTED THAT THE FIRING TRIGGER COULD NOT BE ACTIVATED. TRIGGER JAMMED. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9135184 ↗
• MalfunctionSep 23, 2019Retraction Problem

  WOULD NOT REVERSE KNIFE. IT WAS REPORTED THAT DURING THE ENDOSCOPIC LOBECTOMY SURGERY, AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. USED KNIFE REVERSE BUTTON TO RETURN KNIFE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104960 ↗
• MalfunctionSep 12, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, AFTER INSERTING INTO TROCAR, DID NOT CLAMP THE TISSUE, SO REMOVED THE DEVICE FROM TROCAR. THERE WAS NO DIFFICULTY CLOSING THE JAWS OF THE DEVICE. FOUND COULD NOT OPEN THE JAW AND THE JAWS OF DEVICE NEVER EVENTUALLY OPENED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9014685 ↗
• MalfunctionSep 9, 2019Retraction Problem; Failure to Fire

  IT WAS REPORTED THAT DURING THE THORACOSCOPIC LOBECTOMY SURGERY, COULD NOT FIRE FARTHER AFTER USING A GREEN STAPLE ON BRONCHI. AND THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON COULD NOT WORK. USED MANUAL OVERRIDE LEVER TO RETURN KNIFE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8976237 ↗
• MalfunctionJul 12, 2019Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ECHELON FLEX DID NOT FIRE. THE RELOAD WAS PLACED PROPERLY. THE REVERSE BUTTON WAS USED BUT IT WENT DIFFICULT. NO PATIENT CONSEQUENCES; THEY TOOK ANOTHER EC60 TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787002 ↗
• MalfunctionJul 9, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RADICAL SIGMOIDECTOMY SURGERY, COULD NOT CLOSE THE JAW BEFORE INSERT INTO TROCAR. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8771079 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE WEDGE RESECTION OF LUNG SURGERY, THERE WERE NO AIR LEAKS OR BLEEDING, BUT PULMONARY HEMATOMA AND BLOODY SPUTUM OCCURRED ONE DAY AFTER SURGERY. THE PATIENT IS STILL IN THE HOSPITAL FOR OBSERVATION NOW.

  Patient problems: Blood Loss; Hematoma; No Code Available

  MAUDE report 8748449 ↗
• MalfunctionJun 7, 2019Retraction Problem

  IT WAS REPORTED THAT DURING THE THORACOSCOPIC RESECTION OF RIGHT MIDDLE PULMONARY NODULE SURGERY, AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT WOULD NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON WOULD NOT WORK. USED ANOTHER DEVICE TO REMOVE THE EC60 FROM THE PATIENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8680774 ↗
• MalfunctionJun 6, 2019Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE THORACOSCOPIC RIGHT UPPER LOBECTOMY SURGERY, COULD NOT OPEN THE JAW. USED ANOTHER DEVICE TO CUT THE TISSUE AND REMOVED THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676500 ↗
• MalfunctionMay 21, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC GASTRECTOMY SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627782 ↗
• MalfunctionMay 15, 2019Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RADICAL RESECTION OF LUNG CANCER SURGERY, WHEN SEVERING OBLIQUE FISSURE OF RIGHT UPPER AND MIDDLE LOBES TISSUE, AFTER FIRED, NOTED THE ABUNDANT STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8612228 ↗
• MalfunctionApr 24, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE LOBECTOMY SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8543742 ↗
• MalfunctionApr 18, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE HEPATECTOMY SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8528098 ↗