ECHELON Flex ENDOPATH PCE60ARecalls & reported problems
Ethicon Endo-Surgery, LLC · Echelon Flex60 Powered Endopath Stapler Compact Articulating Endoscopic Linear Cutter · Class 2
Quick summary
This Ethicon Echelon Flex60 powered endoscopic stapler is used to cut and staple tissue during minimally invasive surgery. The 53 reports mostly describe the stapler failing mid-operation: it would not fire, would not form a proper staple, or the jaw would not open, so surgeons swapped in another device to finish the case. Four reports involve injuries; no deaths are described. Most reports mention no lasting effect on the patient, though a few note bleeding and oozing after firing. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705036014478), received between Feb 2, 2018 and Aug 24, 2026 — classified as 4 injuries, 49 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (16 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.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple16
- Failure to Fire15
- Difficult to Open or Close10
- Activation Failure5
- Mechanical Jam5
- Adverse Event Without Identified Device or Use Problem4
- Retraction Problem3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- No Consequences Or Impact To Patient16
- Hemorrhage/Blood Loss/Bleeding2
- Failure to Anastomose1
- No Code Available1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412889 ↗MalfunctionApr 1, 2026Failure to Fire
IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. 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 24756939 ↗MalfunctionJan 13, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE HAD SUDDEN INABILITY TO USE DURING SURGERY THUS, SERIOUSLY AFFECTING THE OPERATION. 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 24058160 ↗MalfunctionDec 24, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A PNEUMONECTOMY PROCEDURE, IT WAS OBSERVED THAT SOME STAPLES MALFORMED AND OOZING OCCURRED AFTER FIRING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 23888747 ↗MalfunctionAug 22, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THEY COULD NOT OPEN THAT JAW AFTER FIRING. THEY USED THE REVERSE BUTTON TO OPEN THE JAW AND REMOVED 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 22875169 ↗MalfunctionJul 28, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED WITHOUT MOTOR SOUND ON THE THIRD FIRING. 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 LIKE DEVICE WAS USED 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 22630437 ↗MalfunctionMay 12, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT FIRED. ANOTHER LIKE DEVICE WAS USED 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 22003756 ↗MalfunctionMay 12, 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 22003727 ↗MalfunctionJan 10, 2025No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, AFTER FIRED, THE STAPLE LINE AND CUT LINE ARE BOTH COMPLETE. NOTED OOZING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 21123435 ↗MalfunctionJun 7, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE UNK 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 19491042 ↗MalfunctionFeb 9, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE UNK SURGERY, DEVICE COULD NOT FIRE FARTHER AFTER FIRED HALF WHEN SEVERING LUNG TISSUE . 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 18676008 ↗MalfunctionJan 17, 2024Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE. 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 CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526780 ↗InjuryNov 20, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
POST-OP BLEEDING. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE. HOWEVER, AFTER THE SURGERY, THE PATIENT EXPERIENCED HEMOPTYSIS IN PACU. GASTROSCOPE CHECK FOUND BLEEDING. USED CLIPS TO CONTROL BLEEDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18169977 ↗InjuryNov 20, 2023Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
POST-OP BLEEDING. IT WAS REPORTED THAT THE SURGERY WAS COMPLETED WITHOUT ANY ISSUE. HOWEVER, AFTER THE SURGERY, THE PATIENT EXPERIENCED HEMOPTYSIS IN PACU. GASTROSCOPE CHECK FOUND BLEEDING. USED CLIPS TO CONTROL BLEEDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18169786 ↗MalfunctionSep 14, 2023Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER FOUR 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 CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745993 ↗MalfunctionAug 3, 2023Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. OUR CUSTOMER SUSPECT IT WAS BATTERY ISSUE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17451931 ↗MalfunctionMay 2, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, COULD NOT OPEN THE JAW. AS THE TISSUE WAS CUT OFF, REMOVED THE DEVICE FROM THE PATIENT THROUGH TISSUE GAP. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16856881 ↗MalfunctionMay 2, 2023Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, COULD NOT OPEN THE JAW. AS THE TISSUE WAS CUT OFF, REMOVED THE DEVICE FROM THE PATIENT THROUGH TISSUE GAP. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854556 ↗MalfunctionApr 6, 2023Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close
IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE AND COULD NOT OPEN THE JAW. 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 16691473 ↗MalfunctionMar 1, 2023Failure 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 16460589 ↗MalfunctionFeb 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE SURGERY, NOTED THE SPRING FALLS OFF. 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 16298766 ↗MalfunctionJan 18, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close
THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, COULD NOT OPEN THE JAW, AND A SMALL SPRING FELL FROM THE GAP OF THE RED EXCITATION KEY . CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16197586 ↗MalfunctionOct 27, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER TWO 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 CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15681182 ↗MalfunctionOct 20, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE SURGERY, COULD NOT FIRE WITHOUT MOTOR SOUND ON THE 1ST FIRING. THE SURGEON REMOVED THE BATTERY AND ROTATED FOR 180 DEGREE AND REINSERTED THE BATTERY. THE DEVICE STILL COULD NOT FIRE AND WITHOUT MOTOR SOUND. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 15639250 ↗MalfunctionOct 10, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 15573393 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.