AEM® Shield Disposable Electrode, L-Diamond FC0311+Recalls & reported problems
Encision, Inc. · 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 10815288014215), received between Aug 14, 2023 and Aug 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2023Improper or Incorrect Procedure or Method; Material Split, Cut or Torn; Improper or Incorrect Procedure or Method; Material Split, Cut or Torn
DURING A LAP CHOLE PROCEDURE, THE USER REPORTED THAT FLECKS OF INSULATION AT THE TIP OF THE DISPOSABLE FIXED-TIP ELECTRODE (PART NUMBER FC0311+) WERE SHEARED OFF. THE CUSTOMER REPORTED THAT FLECKS OF THE MATERIAL FELL INTO THE PATIENT AND HAD TO BE RETRIEVED. THERE WAS NO REPORT OF INJURY OR DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17541637 ↗
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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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