Spencer Probe Depth Electrode SD08R-SP10X-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 00841823107718), received between Jan 8, 2019 and Jan 8, 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.
MalfunctionJan 8, 2019Material Separation; Material Separation
ON DECEMBER 10, 2018, AD-TECH RECEIVED A SUS VOLUNTARY EVENT REPORT (FREEDOM OF INFORMATION (FOI) FOR MANUFACTURERS), MW5081552, FROM THE FDA. THE MEDICAL DEVICE REPORT (MDR) WAS VOLUNTARILY FILED BY THE CUSTOMER AFTER THEY EXPERIENCED AN ISSUE THAT INVOLVED AN AD-TECH DEPTH ELECTRODE. THE REPORT STATED THAT THE PATIENT UNDERWENT A CRANIOTOMY IN THE OPERATING ROOM FOR DEPTH ELECTRODES PLACEMENT TO ALLOW FOR INVASIVE EEG MONITORING ON THE INPATIENT UNIT. DURING THE PLANNED ELECTRODE REMOVAL AT BEDSIDE, THE DISTAL END OF THE 8-CONTACT DEPTH ELECTRODE WAS RETAINED. ONE OF THE DEPTH ELECTRODES HAS A SHEAR IN IT JUST PAST THE FIRST CONTACT. ACCORDING TO REPORT MW5081552, THE CUSTOMER CATEGORIZED THIS EVENT TYPE AS "SERIOUS INJURY" REQUIRING INTERVENTION. AD-TECH REQUESTED ADDITIONAL INFORMATION IN REGARDS TO THIS EVENT. TO DATE, THE CUSTOMER HAS NOT RESPONDED BACK. IT IS UNKNOWN WHAT THE OUTCOME OR CURRENT STATUS IS OF THE PATIENT. A SUPPLEMENT REPORT WILL BE INITIATED SHOULD AD-TECH RECEIVE ADDITIONAL INFORMATION RELEVANT TO THIS MEDWATCH REPORT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8227138 ↗
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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