Subdural Electrode TS08R-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 00841823108197), received between May 31, 2024 and May 31, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Device Problem Information1
Material Separation1
Material Twisted/Bent1

Patient problems

Foreign Body In Patient1
Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 31, 2024Material Separation; Material Twisted/Bent; Insufficient Device Problem Information; Material Separation; Material Twisted/Bent; Insufficient Device Problem Information
A CUSTOMER REPORTED THAT ELECTRODE STRIP WAS BENT AND 2 CONTACTS SEPARATED FROM THE STRIP AND HAD TO BE RETRIEVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 19434718 ↗

Device details

UDI-DI	`00841823108197`
Brand	Subdural Electrode
Model	TS08R-SP10X-000
Company	Ad-Tech Medical Instrument Corporation
Product code	GYC · ELECTRODE, CORTICAL
Class	Class 2
FDA submission	K191186
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 9, 2026

Device type (GMDN): Cortical electrode

A sterile, invasive, electrical conductor that is temporarily placed (< 30 days) on the surface of the brain to stimulate the brain or to record the brain's electrical activity (with more precise localization than a scalp electrode). It is typically a series of discs mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The implanted device, also known as a subdural electrode, is connected to recording, monitoring, or stimulation/response devices [e.g., electroencephalograph (EEG), evoked-potential recorder, stimulator]. This is a single-use device.

Other ELECTRODE, CORTICAL devices

Subdural Electrode TS06R-SP10X-000
Ad-Tech Medical Instrument Corporation · ELECTRODE, CORTICAL
2 reports
Subdural Electrode TS04R-SP10X-000
Ad-Tech Medical Instrument Corporation · ELECTRODE, CORTICAL
1 report
NA PE-210AK
Nihon Kohden Corporation · ELECTRODE, CORTICAL
1 report

All ELECTRODE, CORTICAL devices →

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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