ECHELON ENDOPATH SC60Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705036002703), received between Nov 22, 2017 and Oct 24, 2018 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2018Retraction Problem

  IT WAS REPORTED THAT COULD NOT RETURN BLADE. DURING THE ENDOSCOPIC PULMONARY BULLAE, AFTER FIRED, COULD NOT RETURN THE BLADE, USED MANUAL RELEASE LEVER TO RETURN THE BLADE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8000989 ↗
• MalfunctionOct 17, 2018Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN SIGMOIDECTOMY, THE DEVICE COULD NOT BE FIRED AT THE FIRST FIRING ON THE COLON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975875 ↗
• MalfunctionApr 24, 2018Failure to Form Staple

  IT WAS REPORTED THAT THE STAPLES MALFORMED AFTER FIRING. DURING THE VATS LOBECTOMY, AFTER FIRED WITH ECR60B, WHEN SEVERING THE LOBE OF LUNG, FOUND THE STAPLES MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454672 ↗
• MalfunctionDec 15, 2017Device Inoperable; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRECTOMY, THE DEVICE WAS LOCKED OUT AT THE FIRST FIRING WHEN THE DEVICE WAS USED FOR ¿DUODENUM RESECTION. THEN, THE JAWS COULD NOT BE OPENED WITH THE ANVIL RELEASE BUTTON. EVENTUALLY, THE JAWS COULD BE OPENED WITH THE BUTTON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120473 ↗
• InjuryNov 22, 2017Failure to Form Staple

  IT WAS REPORTED THAT THE STAPLES MALFORMED AFTER FIRING. DURING THE THORACOSCOPIC RESECTION OF BULLAE OF SUPERIOR LOBE OF RIGHT LUNG, AFTER 1ST FIRED WITH SC60 AND ECR60B, THE STAPLES MALFORMED WITH IRREGULAR SHAPE. CHANGED ANOTHER ECR60B, THE EVENT RE-HAPPENED. CHANGED EC60 WITH ECR60D, THE EVENT RE-HAPPENED. CHANGED EC60A WITH ECR60D, THE EVENT RE-HAPPENED. THE PATIENT LOST ABOUT 200ML BLOOD WITHOUT TRANSFUSION. THE SURGERY WAS CHANGED TO OPEN SURGERY, AND DELAYED ABOUT 30 MINUTES. USED TLC75 TO COMPLETE THE SURGERY. THE PATIENT IS STABLE AND IN HOSPITAL NOW.

  Patient problems: No Code Available

  MAUDE report 7053051 ↗