MyoSure Tissue Removal Device 10-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045504813), received between Mar 5, 2019 and Mar 5, 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.

• InjuryMar 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MYOSURE TISSUE REMOVAL PROCEDURE WAS COMPLETED. AT THE END OF THE CASE THE PHYSICIAN VISUALIZED A POSTERIOR UTERINE PERFORATION IN THE BOTTOM THIRD OF THE UTERINE CAVITY AREA. A LAPAROSCOPY WAS PERFORMED TO SUTURE AND CLOSE THE LACERATION. THEY DID NOT VISUALIZE A BOWEL INJURY. THE ENDING FLUID DEFICIT WAS 2000ML OF NORMAL SALINE. IT WAS UNKNOWN IF THE PATIENT WAS BEING ADMITTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Uterine Perforation

  MAUDE report 8391022 ↗