Spencer Probe Depth Electrode SD04R-SP05X-000Recalls & reported problems
Ad-Tech Medical Instrument Corporation · Class 2
All models of Spencer Probe Depth Electrode (16)
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 00841823107527), received between May 1, 2019 and May 1, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
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.
MalfunctionMay 1, 2019Material Separation; Material Separation
ON (B)(6) 2019 AD-TECH'S CANADIAN DISTRIBUTOR SENT AN EMAIL THAT WAS RECEIVED FROM ONE OF THEIR CUSTOMERS NOTIFYING HIM OF AN ISSUE THEY EXPERIENCED WITH AN AD-TECH DEPTH ELECTRODE. THE REPORT RECEIVED STATED THE FOLLOWING, "PATIENT WAS HAVING FOUR DEPTH ELECTRODES INSERTED FOR EPILEPSY MONITORING. WHEN ATTEMPTING TO ADVANCE ONE ELECTRODE, IT BECAME CAUGHT ON THE DRILLED EDGE OF THE SKULL AND WHEN THE SURGEON ATTEMPTED TO REMOVE IT THE ELECTRODE BROKE OFF AND WAS LODGED IN THE PATIENT'S BRAIN." IN A LATER SECOND SURGERY (TO REMOVE THE THREE REMAINING ELECTRODES), THE PIECE OF THE FOURTH ELECTRODE WAS ALSO REMOVED AT THAT TIME.". ACCORDING TO THE DISTRIBUTOR'S CUSTOMER PRODUCT FEEDBACK REPORT, THERE WAS MINIMUM HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8571114 ↗
Other ELECTRODE, DEPTH devices
- Spencer Probe Depth Electrode SD04R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- Spencer Probe Depth Electrode SD06R-AP58X-000Ad-Tech Medical Instrument Corporation · ELECTRODE, DEPTH1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 reports
- NA MICRODEEP DEPTH ELECTRODEDixi Medical · Electrode, Depth1 recall0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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