Tri-Tome pc G26826Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002268265), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjuryNov 15, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK TRI-TOME PC TRIPLE LUMEN SPHINCTEROTOME. PER COMPLAINT EMAIL: "THE WIRE GUIDE PORT SLEEVE (BLACK COVER OVER GUIDE WIRE PORT) CAME OFF OF THE SPHINCTEROTOME [WHILE REMOVING THE SPHINCTEROTOME FROM THE ENDOSCOPE] AND WAS INSIDE CHANNEL OF THE ENDOSCOPE. ANOTHER DEVICE WAS PASSED DOWN THE ENDOSCOPE, PUSHING THE SLEEVE OUT OF THE ENDOSCOPE AND INTO THE PATIENT'S BILE DUCT. THE PIECE WAS RETRIEVED VIA FORCEPS. NOTHING WAS LEFT BEHIND, NO HARM TO THE PATIENT."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7035507 ↗