Utrecht Interstitial Fletcher CT/MR Applicator 110270A02-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717213034648), received between Jul 29, 2020 and Jul 29, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2020Break; Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT A UTERINE PROBE 15° BROKE AFTER PLACEMENT IN THE PATIENT, BETWEEN SURGERY AND MRI BEFORE TREATMENT.

  Patient problems: Foreign Body In Patient; Oversedation

  MAUDE report 10337262 ↗