ENDOPATH 6TB45Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20705036000874), received between Jan 29, 2018 and Sep 6, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (3 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.

• MalfunctionSep 6, 2019Failure to Form Staple

  IT WAS REPORTED THAT THE INSTRUMENT FAILED IN APPLYING LINEAR STAPLES. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8969723 ↗
• MalfunctionJul 9, 2019Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RECTAL RESECTION SURGERY, COULD NOT FIRE WHEN SEVERING RECTUM TISSUE ON THE FIRING. CHANGED ANOTHER RELOAD, COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8772476 ↗
• MalfunctionJun 27, 2018Failure to Fire

  IT WAS REPORTED THAT THE DEVICE COULD NOT FIRE. DURING THE RADICAL RESECTION OF RECTAL CANCER, COULD NOT FIRE. 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 7641456 ↗
• MalfunctionJan 30, 2018Mechanical Jam

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC ANTERIOR RESECTION OF RECTUM, AFTER FIRED, COULD NOT OPEN THE JAW. OPENED THE JAW MANUALLY WITH BIG FORCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227282 ↗
• MalfunctionJan 29, 2018Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RADICAL GASTRECTOMY FOR GASTRIC CANCER, COULD NOT FIRE. CHANGED ANOTHER RELOAD, THE EVENT RE-HAPPENED. 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 7224239 ↗