The Electrode Store PRO-ERRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816022022131), received between Jul 17, 2021 and Jul 17, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionJul 17, 2021Material Fragmentation; Material Fragmentation

  THE TIP OF A STAINLESS STEEL STERILE DISPOSABLE MONOPOLAR EEG NEEDLE ELECTRODE BROKE OFF FROM THE NEEDLE SHAFT DURING NEEDLE ELECTROENCEPHALOGRAPHY (EEG) DIAGNOSTIC EXAMINATION OF A (B)(6)-OLD NEONATE. THE PATIENT (A BABY APPROXIMATELY (B)(6) OLD) HAD UNDERGONE NEEDLE ELECTROENCEPHALOGRAPHY (EEG) MONITORING FOR DIAGNOSIS OF POTENTIAL NEUROLOGICAL OR SEIZURE DISORDERS IN THE NEONATAL UNIT. THE NEEDLE ELECTRODES WERE REMOVED AFTER AN UNKNOWN DURATION, PRIOR TO THE PATIENT UNDERGOING A ROUTINE MRI DIAGNOSTIC SCAN. THE MRI SCAN REVEALED SOMETHING DARK ON THE RIGHT SIDE WHICH CAN BE INDICATIVE OF A FOREIGN OBJECT SUCH AS A METAL. AN X-RAY CONFIRMED THE PRESENCE OF THE TIP OF ONE OF THE STAINLESS STEEL NEEDLES, MEASURED TO BE APPROXIMATELY 3MM LONG AND 1MM TO 2MM BELOW THE SURFACE OF THE SKIN AND ROUGHLY PARALLEL TO THE SCALP. IT WAS EVIDENT THAT THE 3MM TIP - WHICH IS THE SHARP END OF THE NEEDLE AND REPRESENTS APPROXIMATELY 25% OF THE EXPOSED 12MM LENGTH OF THE NEEDLE - HAD AT SOME POINT BETWEEN INSERTION AND REMOVAL OF THE NEEDLE BROKEN OFF FROM THE STAINLESS STEEL NEEDLE SHAFT WHICH WAS STILL CONNECTED TO THE ELECTRODE HANDLE AND WIRE. IN EXAMINING THE PATIENT'S SKIN SURFACE NEAR THE

  Patient problems: Device Embedded In Tissue or Plaque; Inflammation

  MAUDE report 12186197 ↗