Aveta Coral Disposable Hysteroscope 214-251Recalls & reported problems
Meditrina, Inc. · Aveta Coral Disposable Hysteroscope for use with Aveta System · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850006759293), received between Aug 2, 2023 and Jul 9, 2025 — classified as 7 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025Break; Entrapment of Device
PATIENT TO OPERATING ROOM [DATE REDACTED] FOR HYSTEROSCOPY, D&C [DILATION AND CURETTAGE], MYOMECTOMY. AT 1103 IT WAS NOTED THAT A PIECE OF METAL WAS PRESENT ON DISPLAY INSIDE PATIENT UTERUS. IT WAS DETERMINED THAT PART OF THE DISPOSABLE DEVICE HAD BROKEN OFF INSIDE THE PATIENT. 1105 CHARGE RN NOTIFIED. ADDITIONAL INSTRUMENTS CALLED FOR TO REMOVE THE METAL OBJECT. 1112 OBJECT REMOVED FROM PATIENT. SURGICAL AREA REVIEWED FOR ADDITIONAL FRAGMENTS AND INSTRUMENTATION LIKEWISE INSPECTED. SURGEON CONFIDENT ALL FRAGMENTS REMOVED. DISPOSABLE ITEM STORED IN RED BAG WITH PATIENT LABEL AND ITEM INFORMATION STICKER ON OUTSIDE. METAL FRAGMENT PLACED IN SPECIMEN CONTAINER AND ALSO STORED. BAG STORED IN OPERATING ROOM FRONT OFFICE BY CHARGE RN DESK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22456441 ↗MalfunctionNov 19, 2024
ERROR CODE 015 DURING THE SURGICAL REMOVAL OF FIBROIDS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20722819 ↗MalfunctionNov 5, 2024
AVETA CORAL DISPOSABLE HYSTEROSCOPE WOULD NOT CONNECT TO THE EQUIPMENT-READING CONNECT SCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609334 ↗MalfunctionJun 18, 2024
DURING A HYSTEROSCOPY, THE HANDPIECE OF AN AVETA CORAL HYSTEROSCOPE WOULD NOT WORK. MANUFACTURER RESPONSE FOR HYSTEROSCOPE (AND ACCESSORIES), AVETA CORAL DISPOSABLE HYSTEROSCOPE (PER SITE REPORTER). THEY WILL REPLACE THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19557473 ↗MalfunctionFeb 29, 2024
THE PROTECTIVE PLASTIC SHEATH ON THE DISTAL PORTION OF THE HYSTEROSCOPE TORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18817547 ↗MalfunctionJan 5, 2024
VIDEO WAS GOING IN AND OUT. HEALTHCARE PROVIDER TRIED PLUGGING THE DEVICE BACK INTO AVETA MACHINE AND DID NOT WORK. HEALTHCARE PROVIDER HAD TO OPEN A NEW AVETA HYSTEROSCOPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18449591 ↗MalfunctionAug 2, 2023
CAMERA DID NOT WORK. REPRESENTATIVE PRESENT DURING INCIDENT. HYSTEROSCOPE REMOVED FROM FIELD.
Patient problems: Insufficient Information
MAUDE report 17442056 ↗
Other Hysteroscope (And Accessories) devices
- Olympus WA2T430AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)783 reports
- Olympus WA2T412AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)453 reports
- Olympus A22001AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)366 reports
- Olympus WA2T470AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)323 reports
- Olympus A22002AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)297 reports
- Olympus A22003AOLYMPUS Winter & Ibe GmbH · Hysteroscope (And Accessories)198 reports
- n.a. 27040XAKarl Storz GmbH & Co. KG · HYSTEROSCOPE (AND ACCESSORIES)102 reports
- Myosure Reach Tissue Removal Device 10-401FCHologic, Inc. · HYSTEROSCOPE (AND ACCESSORIES)4 deaths99 reports
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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