Subdural Electrode TS04R-SP10X-000Recalls & reported problems
Ad-Tech Medical Instrument Corporation · 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 00841823108012), received between Oct 11, 2022 and Oct 11, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated at the User Facility” (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
- Device Contaminated at the User Facility1
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.
MalfunctionOct 11, 2022Device Contaminated at the User Facility; Device Contaminated at the User Facility
DURING ROUTINE INCOMING INSPECTION THE DISTRIBUTOR NOTED A FOREIGN MATERIAL IN THE STERILE PRODUCT POUCH. THERE WAS NO IMPACT TO PATIENT SAFETY AS THIS WAS IDENTIFIED DURING INCOMING INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15579728 ↗
Other ELECTRODE, CORTICAL devices
- Subdural Electrode TS06R-SP10X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, CORTICAL2 reports
- NA PE-210AKNihon Kohden Corporation · ELECTRODE, CORTICAL1 report
- Subdural Electrode TS08R-SP10X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, CORTICAL1 report
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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