UTS G22430Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002224308), received between Apr 29, 2021 and Apr 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Material Fragmentation; Material Separation; Material Fragmentation; Material Separation

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN USED A COOK UTS PRE-CURVED ULTRA TAPER SPHINCTEROTOME. THE CUTTING WIRE COMPLETELY DETACHED INSIDE THE PATIENTS BODY. THE WIRE WAS UNABLE TO BE FOUND. THIS WIRE WAS UNABLE TO BE FOUND; IT IS UNKNOWN IF IT IS STILL IN THE BODY, OR MAY HAVE CAME OUT DURING REMOVAL OF THE DEVICE AND LOST IN THE PROCEDURE ROOM. IT IS UNKNOWN IF THE DETACHED PORTION OF THE CUTTING WIRE IS STILL IN THE 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: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748257 ↗