MYOSURE HYSTEROSCOPY SET 40-250Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 25420045510323), received between Sep 16, 2019 and Oct 30, 2024 — classified as 3 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT ON OCTOBER 4, AND DURING THE PROCEDURE WAS USED A SET OF OMNI SCISSORS WITH A MYOSURE SCOPE PRIOR TO A MYOSURE PROCEDURE. WHEN THE DOCTOR REMOVED THE SCISSORS FROM THE SCOPE TO INTRODUCE THE MYOSURE DEVICE, THE DOCTOR NOTICED WHAT LOOKED LIKE METAL SHAVINGS IN THE CAVITY. THE DOCTOR INSERTED THE MYOSURE DEVICE INTO THE CAVITY AND REMOVED THE SHAVINGS FROM THE CAVITY PRIOR TO RESECTING ANY TISSUE. THE DOCTOR USED A SECOND SET OF SCISSORS TO COMPLETE THE PROCEDURE AFTER THE MYOSURE PORTION WAS COMPLETED. THE SCOPE AND SCISSORS WERE INSPECTED POST-PROCEDURE AND THERE DID NOT APPEAR TO BE ANY DAMAGE FROM WHAT THEY COULD TELL. THE DOCTOR WAS SATISFIED WITH THE RESULTS OF THE MYOSURE DEVICE REMOVING ANY DEBRIS FROM THE CAVITY; NO DEBRIS WAS LEFT IN THE CAVITY. PATIENT WAS FINE AND WAS NOT KEPT FOR ANY FURTHER OBSERVATION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20573686 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A SEARCH IN THE HEALTH CANADA MEDICAL DEVICE INCIDENT DATABASE HOLOGIC FOUND AN ADVERSE EVENT RELATED TO A MYOSURE HYSTEROSCOPE 40-250 UNDER INCIDENT NUMBER (B)(4). ONLY INFORMATION AVAILABLE FOUND IS THAT THE PATIENT REQUIRED HOSPITALIZATION OR PROLONGED HOSPITALIZATION DUE TO AN UNSPECIFIED TISSUE INJURY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16611308 ↗
• InjuryJul 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SCOPE WAS INSERTED BUT VISUALIZATION WAS LOST. THE SCOPE WAS REMOVED AND RE-INSERTED. THIS WHEN THE PERFORATION OF THE BOWEL AND UTERUS IS BELIEVED TO OCCUR. PATIENT WAS TAKEN TO THE OR FOR PERFORATION REPAIR. "THE PATIENT IS WELL AND DUE TO BE DISCHARGED." NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.

  Patient problems: Bowel Perforation; Uterine Perforation

  MAUDE report 10271352 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED INSERTING THE SCOPE BUT IT WAS CHALLENGING TO INSERT SMOOTHLY. THE PHYSICIAN APPLIED ADDITIONAL FORCE AND INSERTED THE SCOPE. AT THIS TIME A PERFORATION WAS CAUSED. WHEN DEVICE WAS REMOVED FROM THE PATIENT CAVITY, IT WAS BENT. PATIENT WAS PRESCRIBED AN ANTIBIOTIC AND DISCHARGED AS PLANNED. PATIENT IS "DOING GREAT."

  Patient problems: Uterine Perforation

  MAUDE report 9074052 ↗