KVAC ASHA5050-01Recalls & reported problems
Smith & Nephew, Inc. · AMBIENT KVAC IFS WAND · Class 2
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 00817470000252), received between Mar 11, 2019 and Mar 11, 2019 — 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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2019Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE KVAT WAND CAME OFF IN THE MIDDLE OF A HIPSCOPE. THERE WAS A LOT OF PRESSURE AND FORCE BEING APPLIED TO THE TIP AT THE TIME OF THE INCIDENT. AS IS OFTEN THE CASE IN A HIPSCOPE. THE ITEM WAS RETRIEVED SUCCESSFULLY AND THE OPERATION CONTINUED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8406714 ↗
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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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