ECHELON ENDOPATH SC60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 10705036002710), received between Nov 29, 2017 and Jun 19, 2026 — classified as 2 deaths, 5 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (35 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 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Mechanical Problem; Failure to Fire; Difficult to Open or Close; Mechanical Jam; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A VATS WEDGE RESECTION, DURING THE FIRST FIRING TO TRANSECT LUNG PARENCHYMA, THE KNIFE STOPPED PARTWAY WHEN THE FIRING LEVER WAS SQUEEZED AND WOULD NOT MOVE FORWARD. THE RED KNIFE REVERSE LEVER COULD NOT BE PUSHED DOWN, AND THE JAWS COULD NOT BE OPENED, AND THE DEVICE COMPLETELY COULD NOT BE OPERATED. A SALES REP WAS PRESENT AND ATTEMPTED MULTIPLE TIMES TO OPERATE THE DEVICE. HOWEVER, NEITHER THE CLOSING LEVER NOR THE FIRING LEVER WOULD MOVE AT ALL, AND THE RED KNIFE REVERSE LEVER COULD NOT BE PUSHED DOWN. DEPRESSED, THE ARROW INDICATOR ON THE SIDE SHOWED THE ¿-¿ POSITION (TOWARD THE HANDLE SIDE OF THE ECHELON). THE FIRING COUNT NUMBER (WHICH NORMALLY DISPLAYS 1, 2, 3 AFTER FIRING) SHOWED NEITHER A NUMBER NOR A LOCK SYMBOL BUT INSTEAD APPEARED GRAY. REGARDLESS OF THE SEVERAL ATTEMPTS, THE KNIFE COULD NOT BE RETURNED, AND THE JAWS COULD NOT BE OPENED. DUE TO THE UNAVOIDABLE SITUATION, A NEW SC45A WAS OPENED AT THE DOCTOR¿S DECISION AND INSERTED BENEATH THE NON-FUNCTIONING ECHELON. THE NON-FUNCTIONING ECHELON AND THE TRANSECTED TISSUE WERE REMOVED TOGETHER. AFTER REMOVAL, IT WAS NECESSARY TO OPEN THE JAWS TO RETRIEVE THE RESECTED LUNG SPECIMEN. DIRECT MANU

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

  MAUDE report 25562410 ↗
• MalfunctionMay 11, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, AT THE FIRST FIRING, WHEN THE HOSPITAL ATTEMPTED TO FIRE AND OPEN THE ANVIL JAW, THE JAWS COULD NOT BE OPENED. THE JAWS COULD FINALLY OPEN BY USING THE MANUAL OVERRIDE LEVER. 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 25136472 ↗
• MalfunctionMar 4, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE JAWS DID NOT OPEN AT THE 1ST FIRING. THE ANVIL OPENED WHEN A LITTLE FORCE WAS APPLIED. IT COULD BE FIRED WITHOUT ANY PROBLEMS FROM THE 2ND FIRING ONWARDS. THERE WAS NO EFFECT ON THE PATIENT. THE CARTRIDGE COLOR WAS WHITE. 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 24506535 ↗
• InjuryOct 23, 2025Positioning Failure; Failure to Cut; Component or Accessory Incompatibility; Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Failure to Cut; Component or Accessory Incompatibility; Difficult to Open or Close; Mechanical Jam; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY, THE JAWS DID NOT OPEN. EVEN AFTER EMERGENCY TREATMENT WAS PERFORMED, THE JAWS DID NOT OPEN. ALL NECESSARY MEASURES HAVE BEEN TAKEN TO OPEN JAW. THE CARTRIDGE COLOR WAS BLUE. ADDITIONAL SUTURE WAS PERFORMED TO COMPLETE THE CASE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23366691 ↗
• MalfunctionOct 14, 2024Failure to Fire; Failure to Fire

   IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE SURGERY, COULD NOT FIRE. CHANGED ANOTHER RELOAD TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED . ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439028 ↗
• MalfunctionOct 9, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING UNKNOWN SURGERY, THE KNIFE DID NOT MOVE AND NO FEEDBACK AT THE 3RD STROKE OF THE FIRST FIRING, AND THE DEVICE COULD NOT BE FIRED. THE DEVICE WAS USED ON A COLON. THE CARTRIDGE COLOR WAS BLUE. 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 20410280 ↗
• 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 SC60A - BATCH NUMBER R93P5 ¿ SUSPICIOUS OF TAMPERING ¿ BATCH IS INVALID FOR THIS PRODUCT. THIS BATCH IS RELATED TO THE PRODUCT EC45A ¿ LABEL IS NOT FROM J&J.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250343 ↗
• MalfunctionJul 16, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, STAPLE GUN HAD A SAFETY LOCK OUT. EVEN WHEN A NEW RELOAD WAS USED, THE GUN STILL WOULD NOT FIRE. THE SURGERY WAS NOT DELAYED AND THEY OPENED A NEW J&J DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO FRAGMENTS WERE GENERATED AND NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19753918 ↗
• MalfunctionJul 3, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LOBECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 19665764 ↗
• MalfunctionJun 26, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 19614326 ↗
• MalfunctionJun 12, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE JAWS DIDN'T CLOSE ALL THE WAY. AT THE TIME OF THE CALL IT WAS UNKNOWN HOW THE CASE WAS COMPLETED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19518499 ↗
• MalfunctionMay 9, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. REPEATED MANY TIMES TO RETURN KNIFE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277536 ↗
• MalfunctionMay 2, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 19229926 ↗
• MalfunctionApr 26, 2024Mechanical Problem; Difficult to Open or Close; Mechanical Jam; No Apparent Adverse Event; Mechanical Problem; Difficult to Open or Close; Mechanical Jam; No Apparent Adverse Event

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

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

  MAUDE report 19196922 ↗
• MalfunctionApr 26, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLER DID NOT WORK PROPERLY AND LEFT THE TISSUE OPEN TWICE. THE RELOADS DO NOT FORM PROPERLY AND LEAVE THE TISSUE OPEN. THE SURGERY WAS DELAYED BY AN UNK AMOUNT OF TIME AND WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192959 ↗
• MalfunctionApr 24, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 19173262 ↗
• MalfunctionApr 19, 2024Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event; Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LUNG WEDGE RESECTION, THE SURGEON CLOSED DOWN THE STAPLER (WITH A BLACK RELOAD) ON LUNG FISSURE AND ARTERY AND TRIED TO FIRE THE DEVICE. THE DEVICE LOCKED OUT AND STARTED TO TEAR THE ARTERY. THE SURGEON DECIDED TO OPEN ANOTHER DEVICE AND PLACE IT BELOW THE FAULTY DEVICE AND FIRE SUCCESSFULLY AND THEN REMOVE THE LUNG TISSUE AND FAULTY DEVICE. HE DID NOT WISH TO USE THE REVERSE LOCKOUT DUE TO THE SITUATION OF THE ARTERY. THE SURGERY WAS PROLONGED BY 30 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19145125 ↗
• MalfunctionApr 5, 2024Difficult to Open or Close; Mechanical Jam; Difficult to Open or Close; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THEY WERE UNABLE TO RETURN THE KNIFE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19051041 ↗
• DeathJan 5, 2024Failure to Form Staple; Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  IN THE PROCEDURE, THE STAPLER DOES NOT CUT THE TISSUE AND LIKEWISE THE RELOADING DOES NOT STAPLE. 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, (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: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18452910 ↗
• MalfunctionDec 20, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING PROCEDURE AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 18367516 ↗
• MalfunctionDec 20, 2023Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT DURING A COLECTOMY, THE DEVICE WAS USED INSIDE THE BODY CAVITY. THEN, THE ENTIRE CARTRIDGE CAME OFF DURING USE. THERE WERE NO STAPLES OR OTHER RESIDUES IN THE BODY. AFTER ANASTOMOSIS, THE DEVICE LOCKED OUT WHEN THE SURGEON ATTEMPTED TO FIRE WITH THE DISLODGED CARTRIDGE AGAIN. 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 18367260 ↗
• MalfunctionDec 1, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT WHEN THE SC60A WAS USED TO CONDUCT LAPAROSCOPIC GASTRECTOMY, THE GUN COULDN'T FIRE. THUS, THE DOCTOR TOOK ANOTHER NEW SC60A TO USE. HOWEVER, HE FOUND IT'S HARD TO PRESS FIRING TRIGGER SO HE PRESSED FIRING TRIGGER HARDLY AND THE STAPLES WERE MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249082 ↗
• MalfunctionNov 21, 2023Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 18183589 ↗
• MalfunctionJul 27, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT DURING THE SURGERY, ABNORMAL SOUND WAS DETECTED DURING PROCEDURE. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17409814 ↗
• MalfunctionJul 7, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE  SURGERY, ON THE FIRST AND SECOND FIRING , NOTED OOZING FROM THE TISSUE SECTION . 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 17279920 ↗