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Olympus A22258ARecalls & reported problems

OLYMPUS Winter & Ibe GmbH · HF-resection electrode, roller · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761021623), received between Nov 14, 2022 and Nov 14, 2022 — classified as 1 injury.

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 16, 2026.

Most reported problems

Device problems

  • Break1
  • Fracture1
  • Material Fragmentation1
  • Mechanical Problem1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 14, 2022Break; Fracture; Material Fragmentation; Mechanical Problem; Break; Fracture; Material Fragmentation; Mechanical Problem

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE, THE BALL AT THE DISTAL END OF THE HF EECTRODE BROKE OFF AN FELL INTO THE PATIENT'S UTERUS. THE INTENDED PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. AN ULTRASOUND EXAMINATION WAS PERFORMED WHICH CONFIRMED THAT THE FRAGMENT WAS STILL IN THE UTERUS. UPON THE PATIENT'S REQUEST TREATMENT IS TO BE CONTINUED AT ANOTHER HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Foreign Body In Patient

    MAUDE report 15787674 ↗

Other Hysteroscope (And Accessories) devices

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Sources and updates

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