UTS G22490Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002224902), received between May 22, 2019 and May 8, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN COMMON BILE DUCT, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. IT WAS INITIALLY REPORTED THAT THE SPHINCTEROTOME WAS ADVANCED DOWN THE SCOPE AND THE ASSISTANT BOWED PER THE DOCTOR¿S INSTRUCTIONS. A SPHINCTEROTOMY WAS STARTED. THE DR STOPPED USING CAUTERY TO SEE IF THEY LIKED THE SIZE OF THE CUT. THE DR DECIDED TO EXTEND THE CUT AND STEPPED ON THE PEDAL AGAIN AND THAT¿S WHEN THE CUTTING WIRE BROKE. THE DR DECIDED TO NOT CONTINUE WITH THE SPHINCTEROTOMY SO THEY REMOVED THE DEVICE FROM THE SCOPE, KEEPING THE METII-21-480 WIRE IN PLACE AND THEN USED AN OLYMPUS BALLOON EXTRACTOR. THE ISSUE WITH THE CUTTING WIRE DID NOT CAUSE ANY ISSUES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THAT TIME. THE DEVICE WAS RECEIVED ON 15APR2026 AND DETERMINED TO HAVE A PIECE MISSING DURING INVESTIGATION [CUTTING WIRE BREAKS AND SECTION IS MISSING - SUBJECT OF REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN IN 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 AD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127001 ↗
• MalfunctionNov 4, 2024Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. IT WAS REPORTED THAT WHEN THE ASSISTANT REMOVED THIS PRODUCT FROM THE PACKAGE, SHE NOTICED THE CUTTING WIRE WAS NOT IN ITS USUAL PLACE AND SEEMED TO BE PERHAPS 90 DEGREES AROUND THE CATHETER (ORIENTATION ISSUE) [THIS DEVICE MALFUNCTION WAS CAPTURED SEPARATELY]. SHE TRIED TO STRAIGHTEN THE WIRE SO IT WOULD LIE FLAT ON THE CATHETER WHERE IT SHOULD BE WHERE IT SHOULD LIE (WHERE THE CUTTING WIRE ACTUALLY COMES OUT OF THE CATHETER). SHE PUT IT DOWN THE SCOPE AND WHEN IT CAME OUT OF THE SCOPE, IT DID NOT BOW WELL BUT WAS BOWED ENOUGH FOR THE ASSISTANT TO CONNECT TO THE ACTIVE CORD AND THE DOCTOR TO ATTEMPT A SPHINCTEROTOMY. WHEN THE DOCTOR STARTED TO USE CAUTERY, THE DISTAL END OF THE CUTTING WIRE DETACHED AND UP AGAINST THE TISSUE BECAUSE THE TIP OF THE SPHINCTEROTOME WAS INSIDE THE AMPULLA, AND THEN SEEMED TO DETACH ON THE PROXIMAL END. THE CUTTING WIRE SEEMED TO FALL OFF COMPLETELY AND THE DOCTOR LOOKED FOR SEVERAL MINUTES BUT COULD NOT FIND IT. THE SPHINCTEROTOME WAS REMOVED. ANOTHER OF THE SAME DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE SPH

  Patient problems: Foreign Body In Patient

  MAUDE report 20603450 ↗
• InjuryJun 13, 2024Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. IT WAS REPORTED THAT A SPHINCTEROTOMY WAS ATTEMPTED (PARTIALLY COMPLETED) WITH A COOK WIRE GUIDE IN THE SPHINCTEROTOME INTO THE CBD (COMMON BILE DUCT) AND THE CUTTING WIRE COMPLETELY DETACHED FROM THE SPHINCTEROTOME. IT BECAME SLIGHTLY EMBEDDED IN THE TISSUE. THE DEFECTIVE SPHINCTEROTOME WAS REMOVED LEAVING THE WIRE GUIDE, AND THEN A NEW DEVICE WAS ADVANCED. THE SECOND SPHINCTEROTOME WAS ABLE TO COMPLETE THE SPHINCTEROTOMY AND IT WAS REMOVED. THE SECOND SPHINCTEROTOME WAS REMOVED AND A SMOOTH EDGED GRASPER WAS ADVANCED DOWN THE SCOPE. IT WAS ABLE TO GRAB THE CUTTING WIRE AND BE REMOVED SUCCESSFULLY. ONCE THE CUTTING WIRE WAS REMOVED, A PLASTIC STENT WAS PLACED AND THE CASE WAS FINISHED SUCCESSFULLY. NO ADVERSE EFFECTS WERE REPORTED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE CUTTING WIRE COMPLETELY DETACHED FROM THE SPHINCTEROTOME AND BECAME SLIGHTLY EMBEDDED IN THE TISSUE. A SMOOTH EDGED GRASPER WAS ADVANCED DOWN THE SCOPE TO GRAB THE WIRE FRAGMENT. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE

  Patient problems: Foreign Body In Patient

  MAUDE report 19527714 ↗
• MalfunctionSep 10, 2020Malposition of Device; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. THE TIP OF THE SPHINCTEROTOME DEFLECTED IN THE WRONG DIRECTION WHEN BOWED. THEY REMOVED THIS ONE FROM THE ENDOSCOPE AND USED ANOTHER OF THE SAME PRODUCT TO COMPLETE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED BY THE CUSTOMER NOTED THE PHYSICIAN PUT THE SPHINCTEROTOME DOWN THE ENDOSCOPE AND IT CAME OUT CLOSER TO 5-6 O'CLOCK (OR UPSIDE DOWN FROM THE USUAL 11-1 O'CLOCK). 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 Consequences Or Impact To Patient

  MAUDE report 10513857 ↗
• MalfunctionMay 24, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOMES. THE ORIENTATION OF THE CUTTING WIRES WAS OFF, CAUSING THE SPHINCTEROTOMES TO BOW LEFT TOWARD 9 O'CLOCK [INCORRECT CUTTING WIRE ORIENTATION]. NO SECTION OF THE DEVICES REMAINED 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 Consequences Or Impact To Patient

  MAUDE report 8640373 ↗
• MalfunctionMay 22, 2019Failure to Align; Failure to Align

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. UPON BENDING THE CUTTING WIRE, THE SPHINCTEROTOME ORIENTATION WAS AT 9 O'CLOCK INSTEAD OF 12 O'CLOCK. THE ORIENTATION WAS COMPLETELY OFF. ANOTHER OF THE SAME DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8633948 ↗