Mara Water Vapor Probe Kit DDK-16-050Recalls & reported problems
Aegea Medical Inc. · Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringe and saline supply line with spiked end. · Class 3
Data updated Oct 18, 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 00857379006030), received between Jul 13, 2021 and Jul 13, 2021 — 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Bowel Burn1
- Bowel Perforation1
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem
ON (B)(6)2021, DR. (B)(6) INFORMED AEGEA OF INJURY OF PATIENT FOLLOWING MARA PROCEDURE. ON (B)(6)2021 DR. (B)(6) FILLED OUT A FORM AND SENT TO AEGEA WITH THE FOLLOWING INFORMATION: MARA PROCEDURE WITHOUT INCIDENT. MARA SAFETY CHECKS WERE COMPLETED ON 1ST TRY. PATIENT IN DISCOMFORT DURING PROCEDURE BUT LEFT IN NO PAIN. A FEW HOURS AFTERWARD, PATIENT WAS ADMITTED THROUGH ER WITH AIR UNDER DIAPHRAM ON CT. TAKEN TO OPERATING ROOM, HAD PERFORATION OF SMALL BOWEL WITH MULTIPLE BURNED AREA OF SIGMOID AND BLADDER. NEEDED RESECTION AND ILEOSTOMY. PROCEDURE WAS COMPLETED ON 61 YR OLD PATIENT WITH 5.5-6CM UTERINE LENGTH.
Patient problems: Bowel Burn; Bowel Perforation; Discomfort
MAUDE report 12160893 ↗
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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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