ECHELON Flex ENDOPATH PSE45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 384 adverse event reports that list this exact device (DI 10705036014317), received between Mar 28, 2013 and Sep 17, 2026 — classified as 1 death, 40 injuries, 343 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (116 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 384 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Cut; Difficult to Open or Close; Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50807772 ↗
• MalfunctionAug 14, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260359 ↗
• MalfunctionAug 14, 2026Positioning Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254402 ↗
• MalfunctionJun 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THEY COULD NOT OPEN THE JAW AFTER FIRING. REPEATED MANY TIMES TO OPEN THE JAW (FOLLOWED UP IFU); AND FINALLY, THEY OPENED THE JAW SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610940 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE; AND HAD NO 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 25610899 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE; AND HAD NO 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 25610856 ↗
• MalfunctionApr 17, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 24915727 ↗
• MalfunctionApr 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROSTATECTOMY 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 24897936 ↗
• MalfunctionMar 24, 2026Material Integrity Problem

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE MANUAL OVERRIDE DOOR FELL OFF IN THE PACKAGING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674749 ↗
• MalfunctionMar 17, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A PULMONARY PROCEDURE, IT WAS OBSERVED THAT THERE WAS BLEEDING AFTER A FIRE OF WHITE RELOAD (NOT THE 1ST FIRE). THE VOLUME OF BLEEDING WAS ABOUT 300CC. SUTURE SEWING WAS USED TO CONTROL THE BLEEDING. AFTER A FIRE OF A BLUE RELOAD, NOTED MALFORMED STAPLES. CHANGED TO ANOTHER COMPETITIVE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618433 ↗
• MalfunctionJan 26, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN 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 24178207 ↗
• MalfunctionJan 5, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 23957445 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS THE DOCTOR PERFORMED THE BYPASS PROCEDURE WITH OUR BARIATRIC KIT (B)(6), BUT THE PATIENT RETURNED TO THE ROOM WITH INTENSE CRAVING AND VOMITING, PRESENTING BLEEDING. PATIENT HAD TO GO TO THE ICU (INTENSIVE CARE UNIT). DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PATIENT RETURNED TO THE ROOM WITH INTENSE CRAVING AND VOMITING, PRESENTING BLEEDING. PATIENT HAD TO GO TO THE ICU.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 23837687 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS THE DOCTOR REPORTED THAT THE PATIENT PRESENTED VOMITING WITH BLOOD AND CLOT IN THE POSTOPERATIVE PERIOD. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? POST OPERATIVE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Vomiting

  MAUDE report 23837668 ↗
• MalfunctionOct 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, THE DEVICE COULD NOT BE FIRED AND HAD NO MOTOR SOUND ON THE FIRING. THE SURGEON REMOVED THE BATTERY AND ROTATED FOR 180 DEGREE AND REINSERTED THE BATTERY. THE DEVICE STILL DID NOT FIRE AND HAD NO 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 23348312 ↗
• MalfunctionOct 17, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOBECTOMY, IT WAS OBSERVED THAT THE CARTRIDGE COULD NOT BE INSTALLED. 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 23327910 ↗
• MalfunctionAug 16, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. 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 22823199 ↗
• MalfunctionAug 16, 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 22823187 ↗
• MalfunctionAug 15, 2025Failure to Form Staple; Difficult to Open or Close; Failure to Form Staple; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. IT WAS FURTHER REPORTED THAT THEY COULD NOT OPEN THE JAW. OPENED THE JAW MANUALLY WITH BIG FORCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22819932 ↗
• MalfunctionAug 15, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE KNIFE MOVED TO THE DISTAL END BUT DID NOT RETURN AUTOMATICALLY. THEY USED REVERSE BUTTON MANY TIMES TO RETURN KNIFE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815934 ↗
• MalfunctionJul 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. 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 22666380 ↗
• MalfunctionJul 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 22637575 ↗
• MalfunctionJun 11, 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 22188215 ↗
• MalfunctionMay 28, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE MANUAL OVERRIDE DOOR FELL OFF FROM THE DEVICE AFTER OPENING THE PACKAGE. 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 22100631 ↗
• MalfunctionMay 23, 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 ON THE 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 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 22078419 ↗