ECHELON FLEX PCEE60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 689 adverse event reports that list this exact device (DI 10705036015017), received between Dec 7, 2017 and Sep 28, 2026 — classified as 3 deaths, 71 injuries, 615 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (226 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 689 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50920167 ↗
• MalfunctionSep 28, 2026Failure to Form Staple; Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917225 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917131 ↗
• MalfunctionAug 25, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50432031 ↗
• MalfunctionAug 20, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50347538 ↗
• MalfunctionJul 27, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50029516 ↗
• MalfunctionJun 25, 2026Difficult to Open or Close; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CARCINOMATOSIS PROCEDURE, TISSUE BECAME TRAPPED IN THE STAPLING DEVICE DOES NOT ALLOW THE JAWS TO OPEN OR PERFORM PROPER STAPLING. THE TEAM OPENED ANOTHER UNIT FROM THE SAME LOT WHICH FUNCTIONED PROPERLY. THERE WERE NO PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621935 ↗
• 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 25612378 ↗
• MalfunctionJun 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PANCREATECTOMY, IT WAS OBSERVED THAT THE KNIFE DID NOT MOVE FORWARD, AND TRANSECTION COULD NOT BE DONE. THE DEVICE WAS NOT USED FOR THE PATIENT. THE CARTRIDGE COLOR WAS BLACK. 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 25566266 ↗
• MalfunctionMay 26, 2026

  STAPLER WAS LOADED WITH 60 MM WHITE LOAD. PHYSICIAN CLAMPED THE INTESTINE, CLAMPED STAPLER DOWN, ATTEMPTED TO FIRE BUT IT DID NOT FIRE. UNABLE TO UNCLAMP STAPLER. HAD TO OPEN TOP OF STAPLER TO MANUALLY RELEASE. STAPLER PASSED OFF, LOAD VERIFIED AS 60 MM. NEW STAPLER OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25276884 ↗
• MalfunctionMay 18, 2026Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING A VATS SEGMENTECTOMY, IT WAS OBSERVED THAT THE KNIFE DID NOT RETURN AFTER FIRING WHEN THE STAPLES WERE DEPLOYED; AND THE JAWS REMAINED CLOSED AND COULD NOT BE OPENED. THE FIRING NUMBER AT WHICH THE ISSUE OCCURRED WAS UNKNOWN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25209512 ↗
• MalfunctionMay 14, 2026Firing Problem

  IT WAS REPORTED THAT DURING A MINIMALLY INVASIVE ESOPHAGECTOMY PROCEDURE, AFTER THE DEVICE WAS FIRED ONCE, THE SAFETY MECHANISM WAS NO LONGER FUNCTIONAL, PREVENTING PROPER ENGAGEMENT OF THE SAFETY FEATURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175058 ↗
• MalfunctionMay 7, 2026Failure to Fire; Difficult to Open or Close; Activation Failure

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE FIRING STOPPED MIDWAY. THE KNIFE REVERSE SWITCH WAS USED BUT THE KNIFE DID NOT RETURN TO THE HOME POSITION, SO THE MANUAL OVERRIDE LEVER WAS USED TO RETURN THE KNIFE. THE CARTRIDGE COLOR WAS WHITE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112108 ↗
• MalfunctionApr 28, 2026Failure to Fire

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DISCHARGED WHILE IN USE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020613 ↗
• MalfunctionApr 27, 2026Manufacturing, Packaging or Shipping Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN OPEN CORONARY ARTERY BYPASS GRAFTING PROCEDURE, IT WAS OBSERVED THAT THE MANUAL OVERRIDE DOOR HAD BEEN OPENED WHEN THEY OPENED THE PACKAGE. THE DEVICE WAS REPLACED WITH ANOTHER BEFORE HANDING OVER TO THE DOCTOR, AND THE PROCEDURE WAS COMPLETED. THE DEVICE WAS NOT USED FOR THE PATIENT. 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 25007244 ↗
• MalfunctionApr 27, 2026Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE JAWS WERE DEFORMED AFTER FIRING AND COULD NOT BE CLOSED PROPERLY SO THEY STOPPED USING IT. 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 25001549 ↗
• MalfunctionApr 17, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN COLECTOMY PROCEDURE, IT WAS OBSERVED THAT THE BATTERY OF THE DEVICE WAS DEAD OUT OF THE PACK. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916032 ↗
• MalfunctionApr 17, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A CCOLECTOMY FOR COLON CANCER, IT WAS OBSERVED THAT THE DEVICE DID NOT FUNCTION AT THE 4TH FIRING. 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 24912048 ↗
• MalfunctionApr 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE FACILITY WAS UPSET THAT THE PRODUCT HAD ONLY 6 MONTH EXPIRATION DATE AFTER IT WAS MANUFACTURED WHICH WAS TOO SHORT. THEY HAD ALREADY USED THE PRODUCT ON THE PROCEDURE AND THEY ALSO DISCOVERED THAT IT WAS ALREADY EXPIRED LAST JANUARY 31, 2026 ACCORDING TO THE LABEL. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911998 ↗
• 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 24864327 ↗
• MalfunctionMar 31, 2026Failure to Fire; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN OPEN THORACIC PROCEDURE, AFTER THE DEVICE RE-CLAMPED THE TARGETED TISSUE ABOUT THREE TIMES, FIRING WAS ATTEMPTED BUT COULD NOT BE PERFORMED, SO ANOTHER DEVICE WAS USED. THIS ISSUE OCCURRED ON THE 2ND OR 3RD OF FIRING. THE TISSUE WAS SLIGHTLY THICK. AFTER REMOVAL AND CHECKING THE DEVICE, THE ANVIL SIDE APPEARED TO BE DEFORMED. THE CARTRIDGE COLOR WAS BLACK. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744353 ↗
• MalfunctionMar 3, 2026Failure to Fire; Difficult to Open or Close; Activation Failure

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED BLADDER TOTAL EXTIRPATION, THE ECHELON COULD NOT BE FIRED AT THE ILEAL CONDUIT. THE STAPLES WERE SLIGHTLY DEPLOYED AT THE 1ST FIRING, BUT THE KNIFE DID NOT MOVE THROUGH AND STOPPED. THE KNIFE REVERSE SWITCH DID NOT FUNCTION, SO IT WAS RELEASED WITH THE MANUAL OVERRIDE LEVER. THE TISSUE WAS NOT CUT, SO THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. 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 24499903 ↗
• MalfunctionMar 3, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A VATS LOBECTOMY FOR LUNG CANCER, THE SCRUB NURSE GRASPED THE CLOSING LEVER TO CLOSE THE JAWS ATTACH THE STAPLE LINE REINFORCEMENT, COMPLETING THE SETTING, AND WHEN SHE TRIED TO RELEASE IT, THE JAWS COULD NOT BE OPENED. THE SURGEON DID NOT DIRECTLY TOUCH IT, BUT THE NURSE, WHO WAS FAMILIAR WITH OPERATING THE ECHELON, HAD DIFFICULTY, SO IT WAS DETERMINED TO BE A DEFECTIVE PRODUCT. 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 24496603 ↗
• MalfunctionFeb 24, 2026Self-Activation or Keying; Difficult to Open or Close; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FORCEPS WERE ACCIDENTALLY FIRED WHILE CLAMPED TOGETHER WITH THE TISSUE, CAUSING THE KNIFE TO STOP. THE KNIFE DID NOT RETURN WHEN USING THE KNIFE REVERSE SWITCH, SO THE MANUAL OVERRIDE WAS USED TO RETURN THE KNIFE. HOWEVER, THE JAWS DID NOT OPEN, SO THE FORCEPS WERE FIRED WHILE CLAMPED, CAUSING THE KNIFE TO STOP. WHEN INTERVIEWED, THE COMMENT WAS, "I THINK THE KNIFE REVERSE SWITCH WAS PRESSED AFTERWARDS, BUT THE JAWS WOULD NOT OPEN." 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 24430966 ↗
• MalfunctionJan 22, 2026Difficult to Open or Close; No Apparent Adverse Event; Activation Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER'S JAW COULD NOT BE OPENED AFTER FIRING. THEY USED MANUAL OVERRIDE LEVER BUT JAWS STILL DID NOT OPEN. SURGEON HAD TO CUT BOWEL ON LEFT AND RIGHT OF STAPLER TO REMOVE THE STAPLER TOGETHER WITH THE BOWEL. 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 24147072 ↗