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Spencer Probe Depth Electrode SD06R-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 00841823107633), received between Dec 12, 2019 and Dec 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 Contamination with Chemical or Other Material1

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.

  • MalfunctionDec 12, 2019Device Contamination with Chemical or Other Material

    ON NOVEMBER 12, 2019, AD-TECH RECEIVED AN EMAIL FROM ONE OF THEIR DISTRIBUTORS STATING THAT DURING THEIR INCOMING INSPECTION OF THE PRODUCT, THEY IDENTIFIED A FOREIGN SUBSTANCE (BLACK INK) IN THE PRODUCT POUCH. THERE WAS NO IMPACT TO PATIENT SAFETY AS THE ISSUE WAS IDENTIFIED DURING INSPECTION AT THE DISTRIBUTOR'S SITE AND WAS NOT DELIVERED TO A CUSTOMER YET.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9461653 ↗

Other ELECTRODE, DEPTH devices

All ELECTRODE, DEPTH devices →

Sources and updates

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