ECHELON ECH60CRecalls & reported problems

Summary

The FDA's MAUDE database contains 197 adverse event reports that list this exact device (DI 10705036034971), received between Jan 4, 2023 and Sep 28, 2026 — classified as 12 injuries, 185 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (85 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 197 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922662 ↗
• MalfunctionSep 28, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922482 ↗
• MalfunctionSep 21, 2026Positioning Failure; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50847046 ↗
• MalfunctionAug 20, 2026Failure to Fire; Difficult to Open or Close; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50348483 ↗
• MalfunctionAug 14, 2026Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255596 ↗
• MalfunctionAug 4, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133393 ↗
• MalfunctionAug 4, 2026Failure to Fire; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132914 ↗
• MalfunctionJul 1, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE THE STAPLER JAWS WOULD NOT OPEN AFTER DEVICE BEING CLOSED AFTER REMOVAL. THE STAPLER HAD BEEN FIRED NORMALLY 5 TIMES. NOT OPENING ¿ TROUBLE SHOOTING ¿ KNIFE REVERSAL, FLICK HANDLE, CHECK SAFETY. NEW STAPLER OPENED. THE SCRUB NURSE THEN USED FINGERS TO OPEN JAWS. PATIENT: NO HARM, NO CHANGE TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25678319 ↗
• MalfunctionJun 26, 2026Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED THORACIC SURGERY, THE DEVICE WAS BEING OPERATED USING PULSE FIRING. THERE WAS NO SOUND OF KNIFE RETURNING, AND THE KNIFE POSITION COULD NOT BE DETERMINED FROM THE DISPLAY. THEREFORE, MANUAL OVERRIDE LEVER WAS USED, AND THE DEVICE WAS REMOVED FROM THE BODY CAVITY. THE STAPLES WERE FORMED PROPERLY. THE CARTRIDGE COLOR WAS BLACK. 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 25634670 ↗
• MalfunctionJun 23, 2026Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING AN EMERGENCY ROOM PROCEDURE, IT WAS OBSERVED THAT THE KNIFE DID NOT RETURN, SO THE MANUAL OVERRIDE LEVER WAS USED. 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 25595884 ↗
• MalfunctionJun 17, 2026Failure to Form Staple; Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING A ROBOT-ASSISTED RIGHT UPPER LOBECTOMY, THERE WERE NO ISSUES WITH CARTRIDGE LOADING, AND THE TISSUE THICKNESS WAS CONSIDERED NORMAL. WHEN CLAMPING, ALTHOUGH IT CAN NORMALLY BE CLAMPED WITH ONE HAND, THE DEVICE WAS MUCH TIGHTER THAN USUAL THAT BOTH HANDS WERE REQUIRED IN THIS CASE. THE DEVICE WAS EVENTUALLY CLAMPED UNTIL A CLICKING SOUND WAS HEARD. DURING FIRING, THE STAPLES WERE DEPLOYED BUT DID NOT ENGAGE THE TISSUE, AND ONLY THE KNIFE MOVED FORWARD. BLEEDING OCCURRED AS A RESULT. AFTER HEMOSTASIS, THE SAME MAIN BODY WAS USED WITH THE GOLD CARTRIDGE FOR THE SECOND AND THIRD FIRINGS. HOWEVER, BOTH HANDS WERE STILL REQUIRED FOR CLAMPING. SOME STAPLES APPEARED TO ENGAGE THE TISSUE DURING THE SECOND AND THIRD FIRINGS. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 25533424 ↗
• MalfunctionJun 9, 2026Device Remains Activated

  IT WAS REPORTED THAT DURING A PARTIAL LUNG RESECTION, THE DEVICE WAS FIRED FOR PARENCHYMAL TRANSECTION AND OPERATED NORMALLY. HOWEVER, THE MOTOR SOUND DID NOT STOP AFTER FIRING. AFTER THE MOTOR SOUND STOPPED, THE DEVICE WAS RELEASED, AND TRANSECTION WAS COMPLETED WITHOUT ISSUE. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25443435 ↗
• MalfunctionJun 1, 2026Self-Activation or Keying; Noise, Audible

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AFTER LOADING A GREEN RELOAD CARTRIDGE INTO THE ECHELON MAIN BODY, AN ATTEMPT WAS MADE TO SET THE STAPLE LINE REINFORCEMENT. HOWEVER, THE ANVIL COULD NOT BE DETACHED FROM THE APPLICATOR. WHILE REPEATEDLY ATTEMPTING THIS, THE DEVICE FIRED UNINTENTIONALLY. AFTERWARD, WHEN THE HANDLE WAS SQUEEZED TO ITS LIMIT (INCLUDING THE PLAY IN THE HANDLE) WITH CLAMPING THE ECHELON, A ¿WHIRRING OPERATING SOUND WAS HEARD¿. THE CARTRIDGE COLOR WAS GREEN. ANOTHER COMPETITIVE 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 25354736 ↗
• MalfunctionJun 1, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SEGMENTECTOMY PROCEDURE, THE STAPLER WAS DEPLOYED AND THE KNIFE RETURNED WITH NO PROBLEM AT THE FIFTH FIRING. HOWEVER, ALTHOUGH THE CLOSING TRIGGER WAS RELEASED AND GRASPING FORCE WAS LOOSE, THE ANVIL JAW REMAINED CLOSING. THE ANVIL JAW WAS OPENED WHEN USING THE FORCEPS AND PULLED. AFTER THE SALES REP TRIED CLOSING AND OPENING THE DEFECTIVE DEVICE, ALTHOUGH THE LEVER REMAINED OPEN, IT COULD FEEL FOR SURE THAT THE ANVIL GOT CAUGHT ON SOMETHING AND KEPT CLOSED. 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 25350987 ↗
• MalfunctionJun 1, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A BRONCHIAL DIVISION, PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED. THE AREA AROUND THE CENTER WHERE SUTURING WAS INCOMPLETE WAS SUTURED BY HAND. 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 25349394 ↗
• MalfunctionMay 12, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A LLAPAROSCOPIC BULLECTOMY, IT WAS OBSERVED THAT THE KNIFE DID NOT MOVE FORWARD SMOOTHLY. WHEN THE BATTERY WAS RE-LOADED AT THE SECOND FIRING, THE KNIFE MOVED FORWARD WITH THE USUAL SENSATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150260 ↗
• MalfunctionMay 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A COLECTOMY FOR COLON CANCER, WHEN THE ECH60C AND THE GST60D WERE USED AT THE SECOND FIRING, THE KNIFE DID NOT MOVE FORWARD. 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 25085727 ↗
• MalfunctionApr 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN THORACIC PROCEDURE, IT WAS OBSERVED THAT THE BATTERY DID NOT OPERATE. ANOTHER DEVICE WAS USED BEFORE LOADING THE CARTRIDGE 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 25033518 ↗
• MalfunctionApr 28, 2026Positioning Failure; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SEMI-OPEN THORACOSCOPIC SEGMENTECTOMY FOR LUNG CANCER, IT WAS OBSERVED THAT THE DEVICE MOVED FORWARD FOR ONE CENTIMETER AND STOPPED FIRING AT THE SECOND FIRING BETWEEN THE SUPERIOR AND INFERIOR LINGULAR SEGMENTS AND WHILE THE LUNG PARENCHYMA WAS RESECTING. THE STAPLES WERE PARTIALLY DEPLOYED. ALTHOUGH THE HOME BUTTON WAS PRESSED, THE KNIFE DID NOT RETURN, AND THE JAWS COULD NOT BE OPENED WITH CLAMPING THE TISSUE, SO THE HOSPITAL USED THE MANUAL OVERRIDE LEVER TO RETURN AND RELEASED THE KNIFE. 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 25021540 ↗
• MalfunctionApr 28, 2026Separation Problem

  IT WAS REPORTED THAT DURING A PARTIAL PNEUMONECTOMY, IT WAS OBSERVED THAT THE TISSUE STUCK TO THE CARTRIDGE AT THE 2ND FIRING AND COULD NOT BE REMOVED; AND THEREFORE, IT WAS GRADUALLY PEELED AWAY FROM THE TISSUE. THERE WERE NO LEAKS AND IT WAS REPORTED THAT THE PATIENT WAS FINE. THE CARTRIDGE COLOR WAS GOLD. ADDITIONAL SUTURE WAS PERFORMED 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 25019813 ↗
• MalfunctionApr 20, 2026Failure to Form Staple; Failure to Cut; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE LOCKED OUT ON A PATIENT. THE STAPLER DID NOT OPEN, THE STAPLE LINE WAS NOT CORRECT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24928086 ↗
• MalfunctionApr 16, 2026Ejection Problem

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACIC SURGERY, THE DEVICE WITH THE CARTRIDGE COULD BE USED PROPERLY AT FIRST. HOWEVER, EXCHANGING THE CARTRIDGE AND BEFORE FIRING AT THE 2ND, THE SCRUB NURSE SAID THAT THE CARTRIDGE COULD NOT BE LOADED. CHECKING THE MAIN BODY, IT WAS FOUND THAT ONE OF PARTS REMAINED INSIDE OF THE JAWS. THE CARTRIDGE COLOR WAS BLACK. 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 24904876 ↗
• MalfunctionApr 14, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, IT WAS OBSERVED THAT THE FIRST FIRING OF THE CASE HAD UNFORMED STAPLE LEGS. THE SURGEON PROCEEDED TO USE THE STAPLER IN THE REST OF THE CASE. LATER ON IN THE CASE THERE WAS ANOTHER FIRING WITH A BLUE LOAD THAT RESULTED IN ONE STAPLE LEG NOT FORMING. THE SURGEON OVERSEWED THAT STAPLE. IN REGARDS TO THE FIRST FIRING WITH MULTIPLE LEGS NOT FORMED, HE HAD TO RE-RESECT AS A RESULT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 24872804 ↗
• MalfunctionApr 9, 2026Failure to Fire; Difficult to Open or Close; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A PARTIAL RESECTION FOR INTERSTITIAL PNEUMONIA, THE CLOSING TRIGGER COULD NOT BE CLOSED BECAUSE LUNGS WERE HARD PERHAPS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829384 ↗
• MalfunctionApr 3, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THEY NOTICED SOME UNFORMED STAPLE LEGS AFTER USING THE ECHELON 3000 STAPLER. ONLY BLUE AND WHITE LOADS WERE USED IN THE CASE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781606 ↗