SureTome SW G61351Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002613515), received between Mar 17, 2026 and Sep 9, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 18, 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.

• MalfunctionSep 9, 2026Material Separation

  During an endoscopic retrograde cholangiopancreatography (ERCP) procedure, the physician used a Cook SureTome SW Sphincterotome. It was reported that the tip of the tome was split. The doctor replaced it with a new tome. The rep is in-servicing the use of this device to ensure they did not strip it all the way to the tip of the tome.A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50695660 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  During an endoscopic retrograde cholangiopancreatography (ERCP) procedure, the physician used a Cook SureTome SW Sphincterotome. It was reported that during cannulation, a perforation of the common bile duct occurred.Patient case records confirmed that the same physician had attempted an ERCP on the same patient the prior Monday, had significant difficulty cannulating, used a needle knife multiple times, cut into the papilla for access, and was ultimately unsuccessful. The case under investigation was therefore a redo attempt. The ERCP was performed for suspected choledocholithiasis, though no stones were confirmed. The physician described a straightforward case: cannulation on the first attempt, the wire guide advancing cleanly into position in the common bile duct, contrast injection with no bowing, no rotation of the tome, and no cut performed. As he advanced the tome further into the duct with contrast still being injected, he observed bile leaking low in the common bile duct near the papilla, immediately withdrew the tome and wire guide, and aborted the procedure. He and the staff noted no defects in the device. Imaging he provided was inconclusive ¿ the fluoroscopic images di

  Patient problems: Perforation

  MAUDE report 50178191 ↗
• MalfunctionMar 17, 2026Sharp Edges

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK SURETOME SW SPHINCTEROTOME. IT WAS REPORTED THAT THE TIP OF THE TOME BROKE AND DETACHED. UPON INVESTIGATION OF THE RETURNED COMPLAINT DEVICE, IT WAS FOUND THAT IT WAS THE TIP OF THE CATHETER THAT HAS BEEN DAMAGED WHILE THE CUTTING WIRE REMAINS INTACT. IT DOES NOT APPEAR THAT ANY PORTION OF THE CATHETER MATERIAL HAS DETACHED, BUT THAT THE PEELED BACK PORTION/GAP AT THE DISTAL TIP LED TO AN APPEARANCE OF A SEGMENT MISSING AT FIRST GLANCE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24621762 ↗