TruClear 7209383Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521746732), received between Dec 3, 2019 and Dec 3, 2019 — 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.

• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TRANSVAGINAL INSERTION UNDER A HYSTEROSCOPY WITH THE USE OF DILATOR, PERFORATION OCCURRED AND PENETRATING INTO THE ABDOMINAL CAVITY, THE OPERATION WAS CHANGED TO LAPAROSCOPIC OPERATION. THE PERFORATED SITE WAS REPAIRED, AND POLYPECTOMY WAS PERFORMED AGAIN UNDER HYSTEROSCOPE USING COMPETITOR'S DEVICE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. THERE WAS TISSUE DAMAGE. THE INCISION SITE WAS EXTENDED BY LESS THAN 3 CM. IT WAS ALSO NOTED THAT THERE WAS DIFFICULTY IN THE INSERTION AND HAD INCREASE IN SIZE.

  Patient problems: No Code Available; Perforation; Tissue Damage

  MAUDE report 9407312 ↗