ECHELON Flex ENDOPATH PSE60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 329 adverse event reports that list this exact device (DI 10705036014324), received between Feb 22, 2013 and Aug 7, 2026 — classified as 3 deaths, 20 injuries, 306 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (95 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 329 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Failure to Form Staple; Failure to Fire

  It was reported that during an unknown procedure, it was observed that the device would not fire. Changed to another one to continue the surgery but the same problem happened again. Changed to another four to continue the surgery, after fired, noted the staples malformed. 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 50179876 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCTOCOLECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612224 ↗
• MalfunctionJun 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT FIRE AND HAD NO MOTOR SOUND. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25446127 ↗
• MalfunctionApr 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT COMPLETE THE STAPLING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25043819 ↗
• MalfunctionAug 28, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912712 ↗
• InjuryJul 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  TITLE:CLINICAL APPLICATION VALUE OF DOMESTIC AND IMPORTED STAPLER BASED ON REAL WORLD DATA ANALYSIS AUTHORS: WANG HONGDAN, ZHANG BENXING, WEI'ANHAI, YANG LI, ZHANG HEHUA CITATION: CHINA MEDICAL EQUIPMENT 2024 APRIL VOL.21 NO.4;DOI: 10.3969/J.ISSN .1672- 8270.2024.04.030 THE AIM OF THIS STUDY IS TO INVESTIGATE AND ANALYZE THE CLINICAL USE VALUE OF IMPORTED AND DOMESTIC BRANDS OF STAPLERS BASED ON REAL WORLD DATA. A TOTAL OF 466 PATIENTS WHO RECEIVED STAPLER ANASTOMOSIS IN DAPING HOSPITAL OF MILITARY MEDICAL UNIVERSITY IN 2022 WERE SELECTED AND DIVIDED INTO IMPORTED STAPLER GROUP (N = 294) AND DOMESTIC STAPLER GROUP (N = 172) ACCORDING TO DIFFERENT BRANDS OF STAPLER USED DURING OPERATION. IN IMPORTED STAPLER GROUP, THERE WERE 194 MALES AND 100 FEMALES, AGED 21-89 YEARS, WITH MEAN ONE OF (62.77 ± 11.88) YEARS. THE DOMESTIC STAPLER USES QELC AND OTHER MODELS OF UNIVERSAL ENDOSCOPIC LINEAR CUTTER STAPLER AND DISPOSABLE LOADING UNIT (CHONGQING MAIKEWEI MEDICAL TECHNOLOGY CO., LTD.) DEC-B160 AND OTHER MODELS OF DISPOSABLE ENDOSCOPIC LINEAR CUTTER STAPLER AND ASSEMBLY (JIANGSU TRIPLE XINGHAI MEDICAL DEVICES CO., LTD.) AND OTHER 8 BRANDS OF MULTIPLE SPECIFICATIONS; THE IMPORTED STAPLER USES

  Patient problems: Fistula; Hemorrhage/Blood Loss/Bleeding; Nausea; Pain; Restenosis; Swelling/ Edema; Vomiting

  MAUDE report 22544025 ↗
• MalfunctionMay 29, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22106429 ↗
• MalfunctionMay 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22046565 ↗
• MalfunctionMay 8, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE OF THE PANCREAS, IT WAS OBSERVED THAT THE JAW ON THE DEVICE COULD NOT BE OPENED AFTER FIRING. THEY USED RBRB AND MANUAL OVERRIDE TO OPEN THE JAW AND REMOVE THE DEVICE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985399 ↗
• MalfunctionApr 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 21866131 ↗
• MalfunctionApr 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21753160 ↗
• MalfunctionMar 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING THE DEVICE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21509017 ↗
• InjuryFeb 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED A PATIENT UNDERWENT A GASTRIC SLEEVE PROCEDURE AND IN THE POST-OPERATIVE PERIOD THE PATIENT DEVELOPED A GASTRIC FISTULA DUE TO A FAILURE IN THE STAPLING, REQUIRING HER TO REMAIN IN THE ICU FOR A LONG PERIOD. HOWEVER, IN A SUBSEQUENT CONVERSATION WITH THE SURGEON RESPONSIBLE FOR THE PROCEDURE, SEEKING MORE CONCRETE INFORMATION, IT WAS EXPLAINED THAT THE GASTRIC FISTULA WAS NOT DUE TO EQUIPMENT FAILURE BUT RATHER DUE TO BRONCHOASPIRATION.

  Patient problems: Adhesion(s); Fistula; Insufficient Information

  MAUDE report 21303567 ↗
• MalfunctionFeb 3, 2025Failure to Fire; Excessive Heating; Failure to Fire; Excessive Heating

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, OPENED THE PACKING, BEFORE USED ON THE PATIENT, NOTED THE BATTERY WAS WITH ABNORMAL HIGH TEMPERATURE AND THEN 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21297492 ↗
• MalfunctionJan 7, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY PROCEDURE, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21096345 ↗
• MalfunctionDec 26, 2024Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A RADICAL PROCEDURE FOR COLON CANCER, IT WAS OBSERVED THAT THE DEVICE WAS DIFFICULT TO FIRE WHEN SEVERING TISSUE. THEN AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 21021222 ↗
• MalfunctionDec 5, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE FARTHER AFTER FIRED A LITTLE. 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 20858073 ↗
• MalfunctionSep 3, 2024Difficult to Open or Close; Activation Failure; Difficult to Open or Close; Activation Failure

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER LOCKED, AND IT WAS NOT POSSIBLE TO RETRACT THE BLADE WITH THE RESET BUTTON, SO IT WAS NECESSARY TO OPEN THE DEVICE TO UNLOCK IT. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127865 ↗
• MalfunctionAug 20, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LUNG RESECTION SURGERY, COULD NOT FIRE WITHOUT MOTOR SOUND. THE SURGEON REMOVED THE BATTERY AND ROTATED FOR 180 DEGREE AND REINSERTED THE BATTERY. THE DEVICE STILL COULD NOT FIRE AND WITHOUT MOTOR SOUND. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20002265 ↗
• MalfunctionAug 9, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19954031 ↗
• MalfunctionAug 5, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN SEVERING PULMONARY SEGMENT PARENCHYMA AND BRONCHI ON THE FOURTH FIRING, AFTER FIRED, NOTED THE STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED ANOTHER TWO TO USE , THEY STILL HAD THE SAME PROBLEM. 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 19907757 ↗
• MalfunctionJun 5, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING UNK PROCEDURE AFTER FIRED, NOTED THE STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471410 ↗
• MalfunctionMay 2, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19232633 ↗
• MalfunctionApr 4, 2024Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19041483 ↗
• MalfunctionMar 29, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19005407 ↗