ECHELON ENDOPATH SC45ARecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10705036002697), received between Jan 8, 2018 and Sep 3, 2026 — classified as 3 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (33 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50586103 ↗
• MalfunctionJul 13, 2026Difficult or Delayed Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25797481 ↗
• MalfunctionMar 11, 2025Failure to Form Staple; Difficult to Open or Close; Failure to Form Staple; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT AFTER THE COMPLETION OF SURGICAL CUTTING, THE DEVICE COULD NOT BE SPRUNG BACK TO OPEN THE JAW. IT OPENED AFTER THE CLAMP WAS PULLED ON THE SAFETY. THEY ALSO NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES, SUTURE WAS USED TO OVERSEW. BUT THERE IS STILL A CONTINUOUS AIR LEAKAGE AFTER SURGERY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576641 ↗
• MalfunctionFeb 18, 2025Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE DEVICE HAD BEEN FIRED 3 PREVIOUS TIMES WITHOUT ISSUE THEN IT WOULDN'T FIRE OR OPEN TO REPOSITION OR JUST REMOVE THE DEVICE ON THE 4TH FIRE ATTEMPT. THE DEVICE GOT STUCK ON THE SPECIMEN TISSUE AS HE USED ANOTHER ENDOCUTTER, PVE35A TO SUCCESSFULLY TRANSECT NEXT TO THIS ENDOCUTTER FOR THE LAST FIRE, WHEN THE DEVICE WAS HANDED TO THE SCRUB TECH STILL ATTACHED TO THE SPECIMEN TISSUE. 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 21405226 ↗
• MalfunctionFeb 3, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A SMALL BOWEL RESECTION WITH THE SURGEON A SC45A LOCKED OUT AND WOULD NOT RELEASE. THE STAPLER WAS REMOVED AND THE CASE WAS FINISHED WITH ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21295004 ↗
• MalfunctionNov 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT THE BLADE OF THE DEVICE NEVER ENGAGED ACCORDING TO THE CUSTOMER. NO ADDITIONAL INFORMATION WAS GIVEN TO THE REP. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20656223 ↗
• MalfunctionSep 18, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT GBP LATAM TEAM PERFORMED A TEST PURCHASE IN COLOMBIA DUE TO A SUSPICIOUS SELLER. PRODUCT SC45A ¿ BATCH K4CK6Z - SUSPICIOUS OF TAMPERING ¿ THIS BATCH INVALID ¿ THERE IS INSCRIPTION ¿MUESTRA SIN VALOR COMMERCIAL¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250783 ↗
• MalfunctionJul 29, 2024Failure to Fire; Failure to Fire

  DURING CLOSURE OF THE JAWS, THE STAPLER BLOCKED AND THE KNIFE DIDN'T FINISH ITS RUN, NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19849525 ↗
• MalfunctionJul 26, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING CLOSURE OF THE JAWS, THE STAPLER BLOCKED AND THE KNIFE DIDN'T FINISH ITS RUN. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839587 ↗
• MalfunctionJul 26, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED DURING CLOSURE OF THE JAWS, THE STAPLER BLOCKED AND THE KNIFE DIDN'T FINISH ITS RUN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19839510 ↗
• MalfunctionJul 22, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE CLOSURE OF THE JAWS, THE STAPLER BLOCKED AND THE KNIFE DIDN'T FINISH ITS RUN. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793410 ↗
• MalfunctionFeb 28, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER THE SURGEON COMPLETED A FEW STAPLE. THE EQUIPMENT FIRING TRIGGER WAS STUCK, SO THE SURGEON CAN'T FIRE THE RELOAD. THE SURGEON DIRECTLY CHANGED TO ANOTHER EQUIPMENT. THERE WAS NO DELAY IN THE SURGERY AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18800571 ↗
• MalfunctionOct 27, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THE SURGEON TRIGGER THE ENDO CUTTER, THE STAPLE COULDN'T PASS THE TISSUE AND STOP. IN THE END, THE SURGEON USE ANOTHER ENDO CUTTER TO STAPLE THE TISSUE. THE SURGERY WAS NOT DELAYED AND WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021329 ↗
• MalfunctionOct 25, 2023Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT THE DEVICE COULD NOT FIRE AND CAN NOT REVISE THE KNIFE. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005809 ↗
• MalfunctionAug 18, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT AFTER A FEW STAPLING, THE SURGEON FELT THE KNIFE GETTING BLUNT. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574589 ↗
• MalfunctionAug 8, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THAT THE DEVICE, CAN NOT FIRE. THE SURGERY WAS NOT DELAYED. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479155 ↗
• MalfunctionMay 2, 2023Difficult to Open or Close; Difficult to Open or Close

  THE ANVIL CAN NOT OPEN, SO IT'S CAN NOT CHANGE NEW RELOAD. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853245 ↗
• MalfunctionMar 8, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE STAPLE NOT GRASP THE TISSUE IN THIRD STAPLE. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16506213 ↗
• MalfunctionNov 15, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN USING THE DEVICE DURING THE SURGERY THE BLADE WAS STOCK. THERE WAS NO DELAY TO THE SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799469 ↗
• MalfunctionNov 2, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DEVICE WAS NOT FUNCTION DURING OPERATION. ONE COULD PRESS THE FIRING TRIGGER, BUT THE DEVICE WAS NOT WORKING. USE THE CLIP ALONG THE ANVIL AND TAKE DOWN THE JAMMED ANVIL. COMPLETED THE SURGERY SAFELY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15716690 ↗
• MalfunctionAug 16, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING THE LAP APPY THE STAPLE LOCKED AFTER FIRING. IT WAS NOT ABLE TO OPEN. UNKNOWN IF THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15232739 ↗
• MalfunctionJul 27, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE SC45A - JAW STUCK. IT CAN'T BE OPEN. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115779 ↗
• MalfunctionJul 27, 2022Difficult to Open or Close; Difficult to Open or Close

  SC45A - JAW STUCK. IT CAN'T BE OPEN. SC45A - JAW STUCK. IT CAN'T BE OPEN. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? UNKNOWN, WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN, WERE FRAGMENTS GENERATED? UNKNOWN, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15115510 ↗
• MalfunctionMay 11, 2022Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT THE DURING A WIG EXCISION LUNG SURGERY. THE KNIFE DIDN¿T COME BACK AFTER THE SECOND FIRING, HAD TO STRUGGLE A LOT BEFORE IT CAME BACK. AFTER TRYING A COUPLE OF MINUTES IT REVERSED FINALLY. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14363103 ↗
• MalfunctionApr 14, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE BLADE COULD NOT BE OPENED DURING SURGERY. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14110713 ↗