OMNI OMNI-G-001Recalls & reported problems
Hologic, Inc. · The Omni Hysteroscopic Grasper is a sterile, single-use, hand actuated hysteroscopic grasper that is intended to be used by a trained gynecologist to provide traction of soft intrauterine tissue. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15420045515734), received between Aug 19, 2026 and Aug 19, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50323844 ↗
Other Hysteroscope accessories devices
- Olympus A4832OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories12 reports
- Olympus A4825OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories8 reports
- OMNI OMNI-S-001Hologic, Inc. · Hysteroscope accessories8 reports
- Olympus A4829OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories8 reports
- CLICKLINE 26312Karl Storz GmbH & Co. KG · Hysteroscope accessories6 reports
- n.a. 26153BIKarl Storz GmbH & Co. KG · Hysteroscope accessories3 reports
- NA M006550340Boston Scientific Corporation · Hysteroscope accessories1 report
- Olympus A4827OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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