ECHELON FLEX PLEE60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1,786 adverse event reports that list this exact device (DI 10705036014614), received between Feb 26, 2016 and Sep 30, 2026 — classified as 6 deaths, 351 injuries, 1,429 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (449 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 1,786 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952156 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Tachycardia

  MAUDE report 50948824 ↗
• MalfunctionSep 21, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845688 ↗
• MalfunctionSep 21, 2026Device Remains Activated; Difficult to Open or Close

  It was reported that during a Sleeve Gastrectomy procedure, first two firings of the stapler went well. On the third firing the stapler stopped firing only after deploying the first staples. When it stopped the stapler continued to make noises like it was firing but in reality it was blocked. To unlock it they removed and put back on the battery. They used the reverse button but it did not unlock. Finally they used the manual override. No patient harm or significant delay has been reported. Additional information requested.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839316 ↗
• InjuryAug 17, 2026No Apparent Adverse Event; Patient Device Interaction Problem

  It was reported that postoperatively to an unknown procedure, the patient was brought back due to bleeding. According to the report, the procedure was thought to have gone well with no concern of bleeding or leaks before closing the patient. Additional information requested.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50282639 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256599 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256598 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256597 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  It was reported that during a Robotic Thoracic procedure, the surgeon attempted to staple the lung tissue with the robotic stapler and it would not clamp. The surgeon then tried an Echelon stapler with a black reload and it partially fired. The surgeon continued to try using the Echelon staplers to complete the transaction, and ended up opening a total of 6 staplers and at least 15 reloads, but finally completed the transection. There were several staplers with bent anvils, indicating that the tissue was beyond limits for the stapler. No surgical delay or patient consequences were reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256596 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256593 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256592 ↗
• InjuryJul 1, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A LEFT UPPER LOBECTOMY PROCEDURE, THE PATIENT¿S LOBE WAS DESCRIBED AS THICK, PREVENTING THE STAPLER FROM CLOSING INITIALLY. THE SURGEON SUBSEQUENTLY FORCED THE DEVICE TO CLOSE AND HELD COMPRESSION FOR TWO MINUTES. UPON FIRING, A LOUD POP WAS HEARD, AND THE KNIFE DID NOT ADVANCE FURTHER. TWO PLEE60A DEVICES REQUIRED MANUAL OVERRIDE TO OPEN. ADDITIONALLY, BOTH PLEE60A DEVICES RAN OUT OF BATTERY CHARGE DURING FIRING, AND THE ANVIL ON THE ECH45L AND ECH60 DEVICES WAS NOTED TO BE BENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25681506 ↗
• InjuryJul 1, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT DURING A LEFT UPPER LOBECTOMY PROCEDURE, THE PATIENT¿S LOBE WAS DESCRIBED AS THICK, PREVENTING THE STAPLER FROM CLOSING INITIALLY. THE SURGEON SUBSEQUENTLY FORCED THE DEVICE TO CLOSE AND HELD COMPRESSION FOR TWO MINUTES. UPON FIRING, A LOUD POP WAS HEARD, AND THE KNIFE DID NOT ADVANCE FURTHER. TWO PLEE60A DEVICES REQUIRED MANUAL OVERRIDE TO OPEN. ADDITIONALLY, BOTH PLEE60A DEVICES RAN OUT OF BATTERY CHARGE DURING FIRING, AND THE ANVIL ON THE ECH45L AND ECH60 DEVICES WAS NOTED TO BE BENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25681498 ↗
• MalfunctionJun 24, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THERE WAS A TOTAL ABSENCE OF COMMANDS FOR THE ECHELON POWERD STAPLER STILL OUTSIDE THE CAVITY, STAPLER WAS REPLACED AND SURGERY PROCEEDED NORMALLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611621 ↗
• MalfunctionJun 8, 2026Separation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS DAMAGED, SOME PARTS WERE STUCK ON PLEE60A AND COULD NOT BE TAKEN OUT. 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 25431598 ↗
• MalfunctionJun 8, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THEY HAD AN ISSUE WITH ONE OF OUR STAPLERS SCREWING UP ON 3RD FIRE AS ONE AREA LOOKED LIKE THE STAPLES DID NOT FORM. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25429194 ↗
• MalfunctionMay 13, 2026Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TIP OF THE JAWS ON THE DEVICE WAS BENT; AND THEREFORE, THEY WERE UNABLE TO CLOSE FULLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164542 ↗
• MalfunctionMay 13, 2026Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY ON THE DEVICE FAILED WHILE IN USE; AND THE DEVICE WAS STUCK ON THE SKIN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164381 ↗
• MalfunctionMay 13, 2026Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BATTERY ON THE DEVICE FAILED WHILE IN USE; AND THE DEVICE WAS STUCK ON THE SKIN. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25164374 ↗
• MalfunctionMay 13, 2026Ejection Problem

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, THEY USED ONE RELOAD WITH NO ISSUES BUT UPON ATTEMPTING TO PUT THE SECOND RELOAD IN STAPLER, NURSE WAS UNABLE TO DO SO; AND SAID IT WAS BLOCKED IN THE JAWS. CHANGED TO A NEW STAPLER AND THE SECOND RELOAD WORKED 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 25164299 ↗
• MalfunctionMay 7, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE STAPLER JAWS CLOSED AS INTENDED BUT DID NOT REOPEN AFTER CLOSURE. AS A RESULT, THE SURGEON WAS UNABLE TO REOPEN THE JAWS. 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 25112921 ↗
• MalfunctionApr 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE, 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 25027764 ↗
• MalfunctionApr 28, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, WHEN TRYING TO FIRE THE DEVICE THE STAPLER MALFUNCTION AND THEY HAD TO USED THE EMERGENCY BAILED OUT TO RETRACT THE KNIFE BLADE. 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 25020967 ↗
• MalfunctionApr 22, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A SLEEVE TO GASTRIC BYPASS CONVERSION PROCEDURE, IT WAS OBSERVED THAT THE STAPLE LINE WAS COMPLETELY FORMED DURING THE GASTRO-ENTERO ANASTOMOSIS. HOWEVER, AFTER A FEW MINUTES IT APPEARED THAT THE STAPLE LINE HAD OPENED UP. UPON INSPECTION OF THE STAPLE LINE, IT INDEED APPEARED LIKE A GAP WAS PRESENT. THE PROXIMAL PART OF THE STAPLE LINE WAS PROPERLY FORMED, AS WAS THE DISTAL PORTION (SMALL PART). HOWEVER, IT SEEMED THAT NO STAPLES WERE PRESENT (THE STAPLE LINE WAS NOT FORMED) IN BETWEEN. UPON INSPECTION OF THE RELOAD THAT WAS USED, DRIVERS WERE VISIBLE ACROSS THE RELOAD. THERE WAS NO ADVERSE CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Failure to Anastomose

  MAUDE report 24954659 ↗
• MalfunctionApr 17, 2026Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLER MISFIRED WHEN CLAMPED ON SPLENIC ARTERY. THEY HAD TO USE MANUAL OVERRIDE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914011 ↗