ENDOPATH TR45GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705036003175), received between Jun 11, 2018 and Jun 30, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER FIRE LOCKED OUT PRIOR TO USE. THE TRIGGER WAS SQUEEZED PRIOR TO FIRE WHEN INSERTED IN TROCAR, ACCIDENTAL. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22354921 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RECTAL CANCER. THE PATIENT HAD HEMATOCHEZIA AFTER RECTAL CANCER SURGERY, AND WAS IMPROVED AFTER INTRAVENOUS DRIP OF HEMOSTATIC DRUGS AND REPEATED INJECTION OF SODIUM CHLORIDE, NOREPINEPHRINE AND HEMOCOAGULASE IN ANAL CANAL. THE PATIENT IS STABLE.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8757413 ↗
• MalfunctionJun 11, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE, USE OF FREE CARTRIDGES SAMPLES RECEIVED FOLLOWING A TENDER BID. ON THE BOX, IT IS NOT INDICATED TO NOT USE THE DEVICE. THE DEVICE CUT BUT DID NOT STAPLE (NO STAPLES IN THE CARTRIDGE). SEVERAL CARTRIDGES FROM DIFFERENT REFERENCES HAVE BEEN USED. USE OF ANOTHER SURGICAL TECHNIQUE TO PERFORM THE CLOSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7587546 ↗