TRUCLEARTM INCISOR Device 72202536Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010654144), received between Mar 6, 2018 and Mar 6, 2018 — classified as 1 injury.

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.

• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING USED TO SAMPLE THE TISSUE INSIDE THE CAVITY DURING HYSTEROSCOPY DILATION AND CURETTAGE, IT PERFED THE UTERUS LEADING TO A EXPLORATORY LAP AND MINI LAP. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. IN ORDER TO RESOLVE THE ISSUE, THEY CHANGED THE HYSTEROSCOPY CASE TO A MINI LAPAROSCOPIC CASE TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS A TEMPORARY SUPERFICIAL BOWEL INJURY AND A BOWEL REPAIR WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF FUNCTION.

  Patient problems: Injury; Perforation

  MAUDE report 7318256 ↗