UTS G22429Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00827002224292), received between Mar 7, 2016 and Jan 22, 2021 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 22, 2021Material Separation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. WHILE DOING THE CAUTERY, THE WIRE BROKE OFF IN THE PATIENT DUODENUM. THE PHYSICIAN SUCKED UP THE WIRE AND IT GOT CAUGHT UP IN THE WORKING CHANNEL OF THE ENDOSCOPE; HOWEVER WAS ABLE TO BE REMOVED WITH NO DAMAGE TO THE ENDOSCOPE. TO COMPLETE THE PROCEDURE THE PHYSICIAN USED ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE ENDOSCOPE SUCTION WAS USED TO REMOVE THE DETACHED PORTION OF THE CUTTING WIRE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11214620 ↗
• MalfunctionNov 23, 2020Malposition of Device; Malposition of Device

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. THE ORIENTATION OF THE TIP WAS BENT IN THE OPPOSITE DIRECTION OUT OF THE PACKAGE. THE PHYSICIAN PUT IT DOWN THE ENDOSCOPE, BUT COULD NOT USE IT, PULLED IT BACK OUT OF THE ENDOSCOPE, AND USED ANOTHER TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT. 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 10886735 ↗
• MalfunctionSep 27, 2019Failure to Align; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED TWO (2) COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOMES. THE TIPS AND WIRES WOULD NOT ORIENT CORRECTLY. 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 9131243 ↗
• MalfunctionApr 26, 2019Failure to Align; Failure to Align

  DURING TWO (2) DIFFERENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED COOK UTS ULTRA TAPER SPHINCTEROTOMES. THEY EXPERIENCED PROBLEMS WITH THE ORIENTATION OF EITHER FOUR OR FIVE (4 OR 5) SPHINCTEROTOMES, UTS-20M. THEY ATTEMPTED TO USE TWO (2) IN ONE PATIENT (SUBJECT OF THIS REPORT) AND EITHER TWO OR THREE (2 OR 3) IN THE OTHER PATIENT (SEE RELATED EMDR 1037905-2019-00224) BUT COULD NOT ACCESS THE COMMON BILE DUCT. THEY THOUGHT THAT VISUALLY THE ORIENTATION OF THE SPHINCTEROTOMES WAS NOT RIGHT. THEY ATTEMPTED TO USE A DIFFERENT BRAND DEVICE ON BOTH PATIENTS AFTER THE UTS-20M FAILED, BUT COULD NOT GAIN ACCESS WITH THIS DEVICE EITHER. 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 Known Impact Or Consequence To Patient

  MAUDE report 8556651 ↗
• MalfunctionApr 26, 2019Failure to Align; Failure to Align

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON 26-APR-2019: "DURING TWO (2) DIFFERENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES, THE PHYSICIAN USED COOK UTS ULTRA TAPER SPHINCTEROTOMES. THEY EXPERIENCED PROBLEMS WITH THE ORIENTATION OF EITHER FOUR OR FIVE (4 OR 5) SPHINCTEROTOMES, UTS-20M. THEY ATTEMPTED TO USE TWO (2) IN ONE PATIENT (SEE RELATED EMDR 1037905-2019-00223) AND EITHER TWO OR THREE (2 OR 3) IN THE OTHER PATIENT (SUBJECT OF THIS REPORT) BUT COULD NOT ACCESS THE COMMON BILE DUCT. THEY THOUGHT THAT VISUALLY THE ORIENTATION OF THE SPHINCTEROTOMES WAS NOT RIGHT. THEY ATTEMPTED TO USE A DIFFERENT BRAND DEVICE ON BOTH PATIENTS AFTER THE UTS-20M FAILED, BUT COULD NOT GAIN ACCESS WITH THIS DEVICE EITHER. ADDITIONAL INFORMATION WAS RECEIVED ON 29-APR-2019 REGARDING THIS REPORT: "PATIENT WAS SCHEDULED TO HAVE AN ERCP PROCEDURE FOR GALLSTONE REMOVAL. A UTS-20M WAS OPENED BUT IT WAS NOTICED UPON REMOVING THE STYLET THAT THE ORIENTATION OF THE TIP WAS INCORRECT (ANGLED TO RIGHT NOT LEFT). IT WAS NOT PLACED DOWN THE SCOPE. ANOTHER UTS-20M WITH A DIFFERENT LOT NUMBER WAS OPENED AND THIS ONE APPEARED TO HAVE THE RIGHT ORIENTATION AND WAS USED TO SUCCESSFULLY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556642 ↗
• MalfunctionFeb 15, 2019Use of Device Problem; Failure to Align; Use of Device Problem; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. THE THREAD WAS UPSIDE DOWN [INCORRECT CUTTING WIRE ORIENTATION]. THEY DID NOT PROCEED WITH THE DEVICE BECAUSE THE TIP WAS BENDING IN THE WRONG DIRECTION. ONE (1) PRIOR TO USE DEVICE WAS ALSO REPORTED. 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 8345366 ↗
• MalfunctionAug 17, 2018Use of Device Problem; Failure to Align; Use of Device Problem; Failure to Align

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. AS REPORTED TO CUSTOMER RELATIONS: ONCE DOWN THE ENDOSCOPE, THE ORIENTATION WAS OPPOSITE OF WHAT IT WAS WHEN IT CAME OUT OF THE PACKAGE [INCORRECT CUTTING WIRE ORIENTATION]. THEY NOTICED THIS WHEN TRYING TO BOW OR FLEX THE TIP. THEY SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. 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 7792787 ↗
• MalfunctionMar 7, 2016Break; Break

  THE CUTTING WIRE BROKE DURING THE PROCEDURE. IT IS UNKNOWN AS TO IF THIS WAS PRIOR TO, DURING, OR AFTER APPLICATION OF CURRENT. ON (B)(6) 2016, THE DEVICE WAS RETURNED FOR EVALUATION. THE CUTTING WIRE WAS BROKEN AND A PORTION WAS MISSING. THE USER FACILITY CONFIRMED THAT NO PORTION OF THE DEVICE REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5483567 ↗