ECHELON Flex ENDOPATH PCE45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 10705036014461), received between Nov 29, 2017 and Mar 11, 2026 — classified as 1 death, 1 injury, 48 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (20 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571352 ↗
• MalfunctionJan 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE AFTER REINSERTING THE BATTERY. THE DOCTOR REPLACED THE BATTERY WITH A NEW ONE, AND THE DEVICE FUNCTIONED PROPERLY THEREAFTER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028431 ↗
• MalfunctionNov 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN 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 23597053 ↗
• MalfunctionJun 30, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED WITHOUT 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 22354952 ↗
• MalfunctionMar 4, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A 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 21516706 ↗
• MalfunctionFeb 10, 2025Failure to Fire; Failure to Fire

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

  MAUDE report 21349263 ↗
• MalfunctionOct 30, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A 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 20567732 ↗
• MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LUNG RESECTION THE SPRING OF FIRING BUTTON FELL OFF DURING THE USE OF STAPLER. 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 20523325 ↗
• MalfunctionSep 10, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LOBECTOMY SURGERY, COULD NOT FIRE WITHOUT MOTOR SOUND ON THE 1TH 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 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 20182733 ↗
• MalfunctionAug 5, 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 19905710 ↗
• MalfunctionNov 15, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE UNK 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 18143031 ↗
• MalfunctionJun 12, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT DURING THE SURGERY, BEFORE USED ON THE PATIENT, NOTED THERE ARE MOLD STAINS FOREIGN MATTERS IN THE PACKING. 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 17107670 ↗
• MalfunctionMar 10, 2023Failure to Fire; Material Integrity Problem; Failure to Fire; Material Integrity Problem

  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 16523261 ↗
• MalfunctionSep 12, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE SURGERY, OPEN THE STERILE PACKING NOTED THE DEVICE WAS DAMAGED. 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 15403106 ↗
• MalfunctionJun 29, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, 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 CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854038 ↗
• MalfunctionFeb 22, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING THE PROCEDURE, VIDEOLAPAROSCOPY SEGMENTECTOMY, THE SURGEON IDENTIFIED SURGICAL STAPLER FAILURE. THE SAME REPORTED THAT IT WAS NOT FIRING, THEN LOCKED AND WAS UNABLE TO UNDOCK. A NEW STAPLER HAS BEEN REQUESTED TO CONTINUE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13582076 ↗
• MalfunctionDec 8, 2021Failure to Fire; Failure 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12964284 ↗
• MalfunctionDec 1, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE SEGMENTECTOMY OF LEFT LUNG 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 12913686 ↗
• MalfunctionNov 22, 2021Failure to Fire; Difficult to Open or Close; Mechanical Jam; Activation Failure; Failure to Fire; Difficult to Open or Close; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT DURING THE RIGHT LUNG SEGMENTECTOMY SURGERY, COULD NOT FIRE WHEN SEVERING LUNG TISSUE ON THE 4TH FIRING. CHECKED THE SLED¿S POSITION, IT IS LOCKOUT ISSUE. CHANGED THE NEW ONE AND THEN 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. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12851560 ↗
• MalfunctionOct 21, 2021Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING THE LOBAR TUMOR RESECTION SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE AND THEN COULD NOT FIRE WHEN SEVERING VASCULAR TISSUE ON THE 2TH FIRING. 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 12674989 ↗
• MalfunctionAug 4, 2021Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LOBECTOMY SURGERY, AFTER THIRD FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. 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 12277027 ↗
• MalfunctionMay 13, 2021Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Mechanical Jam; Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING THE LEFT LUNG TUMOR RESECTION SURGERY, AFTER FIRED WITH TWO ECR45GS, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED ECR45D, COULD NOT FIRE WHEN SEVERING TISSUE ON THE 3RD FIRING AND THEN THE KNIFE IS AT THE DISTAL END AT THIS TIME, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11819382 ↗
• MalfunctionApr 20, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LEFT LUNG TUMOR RESECTION SURGERY, COULD NOT FIRE WHEN SEVERING PULMONARY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11693178 ↗
• MalfunctionMar 23, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING VATS RIGHT UPPER LOBE RESECTION SURGERY, COULD NOT FIRE WHEN SEVERING LUNG TISSUE ON THE SECOND FIRING. CHANGED ANOTHER DEVICE, STILL 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 11553992 ↗
• MalfunctionMar 3, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLER STAPLED, CUT, BUT DID NOT OPEN THE JAW. USED THE MECHANICAL SAFETY RELEASE OF THE STAPLER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405746 ↗