ECHELON FLEX PCEE45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 390 adverse event reports that list this exact device (DI 10705036015338), received between Dec 7, 2017 and Sep 25, 2026 — classified as 1 death, 64 injuries, 325 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (126 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 390 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Material Integrity Problem

  It was reported that during an unspecified surgical procedure, it was observed that the device had a Damaged Manual Override Door. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50898000 ↗
• MalfunctionSep 17, 2026Manufacturing, Packaging or Shipping Problem

  It was reported that during an unknown procedure, it was observed that the device was damaged after opening the package. 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 50806196 ↗
• MalfunctionAug 17, 2026Failure to Fire; Difficult to Open or Close; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286942 ↗
• MalfunctionJun 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT LOCK-OUT OCCURRED IN TWO DEVICES IN A SINGLE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612376 ↗
• MalfunctionMay 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE AT ALL WHEN ABOUT TO FIRE ON THE PULMONARY TISSUE. THE BLADE DID NOT CUT AND NO CLIPS LIGATING. THEY OBSERVED THAT THERE WAS NO ENERGY IN THE BATTERY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25163817 ↗
• MalfunctionMay 13, 2026Failure to Cut; Failure to Fire; No Apparent Adverse Event; Activation Failure

  IT WAS REPORTED THAT DURING A VATS PROCEDURE THE PATIENT HAD INTERSTITIAL LUNG DISEASE. POWERED STAPLERS ARE NOT ABLE TO DIVIDE TISSUES. USED 2 BLACK RELOADS WITH THE MANUAL STAPLER BEFORE IT JAMMED. REVERSE BUTTON NOT WORKING. REQUIRED DIVISION OF LUNG TISSUE WITH HOOK DIATHERMY ¿ AIR LEAK.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25160434 ↗
• MalfunctionMay 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACIC PROCEDURE FOR LUNG CANCER, IT WAS OBSERVED THAT THE FIRING STOPPED MIDWAY. THE TARGETED TISSUE WAS UNKNOWN. THE CARTRIDGE COLOR WAS GREEN. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149999 ↗
• MalfunctionMay 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097622 ↗
• MalfunctionMay 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE ENDOSTAPLER PRESENTED A DEFECT / LOCKING IN THE STAPLING, AND IT WAS NECESSARY TO REPLACE IT WITH A NEW ENDOSTAPLER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097226 ↗
• MalfunctionMay 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN THORACIC PROCEDURE, AFTER THE STAPLE LINE REINFORCEMENT WAS ADHERED TO THE JAWS, THERE WAS A DEFECT. THE DEVICE BECAME UNUSABLE. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094048 ↗
• MalfunctionApr 21, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT STAPLE AS ONE OF THE CARTRIDGES DID NOT STAPLE HALFWAY THROUGH. THE SECOND CARTRIDGE WORKED NORMALLY. THE CARTRIDGE COLOR WAS BLUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944071 ↗
• MalfunctionApr 13, 2026Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event; Activation Failure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON USED PCEE45A WITH A GREEN LOAD, FIRED THE STAPLER, IT SOUNDED LIKE IT WAS GOING AND THEN IT SOUNDED LIKE THE BATTERY DIED. SURGEON SAID THAT IT WOULD NOT OPEN WITH THE REVERSE KNIFE BUTTON SO SURGEON HAD TO USE THE MANUAL OVERRIDE. SURGEON OPENED A NEW STAPLER WITH GREEN RELOAD AND IT DID THE SAME THING. SO SURGEON THEN OPENED A PCEE60A AND IT DID IT AGAIN. SURGEON THEN OPENED A ECH60S AND IT WORKED. THE SURGEON SAID THAT THE TISSUE TORE WHILE USING THE MANUAL RELEASE FUNCTION AND THAT SINCE THE STAPLER DID END UP FIRING A FEW STAPLES AND CUTTING THAT SURGEON HAD TO RESECT MORE TISSUE. IT ADDED AN ADDITIONAL 30 MINUTES TO THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24864319 ↗
• MalfunctionApr 13, 2026Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event; Activation Failure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE SURGEON USED PCEE45A WITH A GREEN LOAD, FIRED THE STAPLER, IT SOUNDED LIKE IT WAS GOING AND THEN IT SOUNDED LIKE THE BATTERY DIED. SURGEON SAID THAT IT WOULD NOT OPEN WITH THE REVERSE KNIFE BUTTON SO SURGEON HAD TO USE THE MANUAL OVERRIDE. SURGEON OPENED A NEW STAPLER WITH GREEN RELOAD AND IT DID THE SAME THING. SO SURGEON THEN OPENED A PCEE60A AND IT DID IT AGAIN. SURGEON THEN OPENED A ECH60S AND IT WORKED. THE SURGEON SAID THAT THE TISSUE TORE WHILE USING THE MANUAL RELEASE FUNCTION AND THAT SINCE THE STAPLER DID END UP FIRING A FEW STAPLES AND CUTTING THAT SURGEON HAD TO RESECT MORE TISSUE. IT ADDED AN ADDITIONAL 30 MINUTES TO THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24864143 ↗
• MalfunctionApr 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A VATS PROCEDURE, IT WAS OBSERVED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800782 ↗
• MalfunctionMar 31, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746734 ↗
• MalfunctionMar 26, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE RELOAD DID NOT "CLICK" INTO PLACE WHEN LOADED AND KEPT FALLING OFF. ANOTHER DIFFERENT ( BATCH NUMBER DIFFERENT) STAPLE WAS LOADED TO IDENTIFY WHAT WAS CAUSING THE ISSUE BUT THE SAME THING HAPPENED AGAIN. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697336 ↗
• MalfunctionFeb 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN OPEN HPB PROCEDURE, THE SURGEON WAS USING A COMPACT ECHELON FLEX STAPLER AND REPORTED THAT THE STAPLER "MISFIRED". 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 24368150 ↗
• MalfunctionFeb 11, 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 24316085 ↗
• MalfunctionFeb 10, 2026Failure to Fire; Difficult to Open or Close; Activation Problem

  VATS LOBECTOMY DEVICE LOCKED ON LUNG TISSUE AND AFTER ATTEMPTS TO REMOVE USING BOTH THE REVERSE BUTTON AND THE MANUAL OVERRIDE, JAWS WOULD STILL NOT OPEN. DEVICE HAD TO BE MANUALLY OPENED USING ANOTHER INSTRUMENT. AN ALTERNATIVE DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304703 ↗
• MalfunctionFeb 9, 2026Excessive Heating

  IT WAS PREOPERATIVELY TO A VATS PROCEDURE; IT WAS OBSERVED BY THE STAFF THAT THE BATTERY AND HANDLE APPEARED TO BE OVERHEATING AND FELT HOT TO TOUCH. THIS WAS OUTSIDE OF THE PATIENT. 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 24293083 ↗
• MalfunctionJan 29, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WOULD DEPLOY STAPLES BUT WOULD NOT CUT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210813 ↗
• MalfunctionJan 29, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WOULD DEPLOY STAPLES BUT WOULD NOT CUT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210811 ↗
• MalfunctionJan 6, 2026Failure 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 23976895 ↗
• MalfunctionDec 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE OF THE LIVER, IT WAS OBSERVED THAT THE HANDLE ON THE DEVICE WOULD NOT RELEASE AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE WITH A DELAY OF 5-10 MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853655 ↗
• MalfunctionDec 18, 2025Failure to Fire; Failure 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 NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840692 ↗