ENDOPATH TSW35Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705036013362), received between Jun 24, 2019 and Jun 24, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2019Difficult to Open or Close

  IT WAS REPORTED THAT ONCE MANUALLY ACTIVATED, THE STAPLER, ON THE NECK OF THE DIVERTICULUM TO MAKE THE ESOPHAGO MARSUPIALISATION, THE STAPLER DOES NOT RE-OPEN AND THE SURGEON ENT EXTRACTS IT WITH THE MATERIAL BETWEEN THE JAWS. THE PATIENT SHOWS A LACERATION OF THE ESOPHAGUS. THEY HAD TO CONVERSION FROM ENDO TO OPEN PROCEDURE. SHE HAD THE NECK OPENED INSTEAD ENDO PROCEDURE. 10 DAY HOSPITALIZATION INSTEAD 1.

  Patient problems: Laceration(s); No Code Available

  MAUDE report 8727298 ↗