DYONICS 7205399Recalls & reported problems
Smith & Nephew, Inc. · FOOTSWITCH EP-1 LOW PROFILE W/ · Class 2
All models of DYONICS (22)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010252036), received between Jul 9, 2019 and Oct 17, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical Shorting” (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
- Electrical Shorting1
- Overheating of Device1
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2019Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE CORD OF THE DEVICE WAS BURNED. IT WAS FOUND BEFORE A PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Patient Involvement
MAUDE report 9205673 ↗MalfunctionJul 9, 2019Electrical Shorting; Electrical Shorting
IT WAS REPORTED THAT BEFORE A PROCEDURE THE DEVICE WAS SHORTING OUT WHEN PLUGGED IN. NO BACKUP DEVICE WAS AVAILABLE. NO DELAY OR PATIENT INVOLVEMENT REPORTED.
Patient problems: No Patient Involvement
MAUDE report 8773648 ↗
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- FMS VUE II 284004Medos International Sàrl · Arthroscope562 reports
- VAPR COOLPULSE 228146Depuy Mitek, LLC · ARTHROSCOPE474 reports
- FMS DUO 284580Depuy Mitek, LLC · ARTHROSCOPE458 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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