UTS G22503Recalls & reported problems
Cook Incorporated · UTS Precurved Ultra Taper Sphincterotome · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002225039), received between Oct 11, 2016 and Oct 11, 2016 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Align” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Align1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2016Failure to Align; Failure to Align
DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK UTS PRECURVED ULTRA TAPER SPHINCTEROTOME. THE PHYSICIAN INSERTED THE DEVICE INTO THE ENDOSCOPE AND WHEN IT EXITED THE ENDOSCOPE, IT WAS NOTED THAT THE ORIENTATION WAS NOT CORRECT. IT WENT IN THE OPPOSITE DIRECTION THAN WHAT IT SHOULD HAVE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6017441 ↗
Other Unit, electrosurgical, endoscopic (with or without accessories) devices
- THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip TB-0535FCOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 recall2 deaths404 reports
- SONICBEAT 5 mm, 35 cm, Front-actuated Grip SB-0535FCOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)379 reports
- Single Use Electrosurgical Knife KD-611LOlympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)1 death357 reports
- Autotome™ RX 44 M00545170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall262 reports
- TRUEtome 44 M00584170Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)237 reports
- Dreamtome™ RX 44 M00584040Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall165 reports
- Dreamtome™ RX 44 M00584050Boston Scientific Corporation · Unit, electrosurgical, endoscopic (with or without accessories)1 recall127 reports
- Single Use 3-Lumen Sphincterotome V KD-V411M-0725Olympus Medical Systems Corp. · Unit, electrosurgical, endoscopic (with or without accessories)160 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page