SureTome SW G61350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002613508), received between Mar 4, 2026 and Sep 17, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Accessory Incompatible” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Separation

  During an endoscopic retrograde cholangiopancreatography (ERCP) procedure, the physician used five (5) Cook SureTome SW Sphincterotomes. It was reported that during a very difficult 5-hour ERCP with challenging patient anatomy and significant scope retroflexion, five SureTome sphincterotomes were used. One of which, was passed down the scope and when exiting tip of scope in patient the doctor noticed the tip looked very malformed. When the device was tested by bowing it, the cutting wire broke. This instance looks like it was a very tough procedure in which multiple sphincterotomes had to be used and one was broken because of scope position.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 50804263 ↗
• InjuryMar 4, 2026Accessory Incompatible; Physical Resistance/Sticking

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK SURETOME SW SPHINCTEROTOME. IT WAS REPORTED THAT THERE WAS SIGNIFICANT RESISTANCE WHEN ADVANCING THE GUIDE WIRE THROUGH THE SPHINCTEROTOME. THIS REDUCED ABILITY TO CONTROL THE WIRE MAY HAVE CONTRIBUTED TO A SMALL PERFORATION OF AN INTRAHEPATIC DUCT. AS A RESULT, A PLASTIC STENT WAS PLACED TO FACILITATE DRAINAGE AND PROMOTE HEALING. FURTHER INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN WAS USING A SURETOME WITH AN ACROBAT 2 ANGLED 035 WIRE GUIDE. THEY FLUSHED THE RACETRACK OF THE WIRE GUIDE AND THE SURETOME LUMEN AND LOADED THE WIRE, AND SOME RESISTANCE WITH NOTED. THEY TIPPED THE WIRE GUIDE TIP IN WATER TO ASSIST. THEY WERE ABLE TO GET THE WIRE GUIDE LOADED. THEY ACCESSED THE DUCT. THE USER NOTED THE WIRE GUIDE FELT "SLIPPERY" BUT THEY WERE ABLE TO MAINTAIN ACCESS. THEY STATED THAT WHEN THEY ADVANCED THE TOME INTO THE DUCT THE WIRE TRAVELED WITH IT. THEY INJECTED SOME CONTRAST AND THERE WAS A SLIGHT BLUSHING INDICATIVE OF A SMALL INTRA HEPATIC DUCT PERFORATION. THEY THEN SWITCHED WIRE GUIDES TO AN ANGLED 035 TERUMO WIRE GUIDE. THE PHYSICIAN NOTED RESISTANCE AFTER THE WIRE SWIT

  Patient problems: Perforation

  MAUDE report 24510162 ↗