NA COAGULATION ELECTRODE AND STOPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03664539002910), received between Jun 17, 2022 and Feb 1, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (K170959); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, DIXI MEDICAL WAS INFORMED VIA THE INTERNAL CUSTOMER COMPLAINT MANAGEMENT SYSTEM OF AN INCIDENT THAT OCCURRED IN DUKE UNIVERSITY HOSPITAL WITH ONE COAGULATION ELECTRODE KIP-ACS-600. AFTER USING FOR 10-12 TRAJECTORIES, THE OPERATING ROOM STAFF AND A PERSON REPRESENTING DIXI NOTICED THAT THE FULL LENGTH OF THE DISTAL PIECE OF PLASTIC TOWARD THE POINTED AND ACTIVE END OF THE DURA COAGULATION ELECTRODE WAS NO LONGER ON THE ELECTRODE. IT WAS NOT FOUND BY THE OPERATING ROOM STAFF AFTER SCANNING THE PATIENT AND SEARCHING THE STERILE FIELD AND OPERATING ROOM. THE SURGEON DID NOT SEEM UPSET AND THEY GOT A NEW DURA COAGULATION ELECTRODE AND IT LASTED THE REMAINDER OF THE CASE, ABOUT 5-7 TRAJECTORIES. ON (B)(6) 2023, DIXI MEDICAL WAS INFORMED VIA AN ADDENDUM OF THE INITIAL CUSTOMER COMPLAINT THAT AFTER REMOVING THE DEPTH ELECTRODES FROM THE PATIENT, DUKE STAFF NOTICED THAT AN ELECTRODE LOOKED LIKE IT MAY HAVE BEEN RETAINED EVEN THOUGH THEY COUNTED ALL ELECTRODES THAT WERE IMPLANTED AND REMOVED AND THEY MATCHED. AFTER INVESTIGATION AND BRINGING THE PATIENT BACK TO SURGERY, THEY FOUND THAT THE REDUCED DIAMETER PIECE OF PLASTIC FROM THE KIP-ACS-600 IN QUESTION WAS LEFT EXTRA AND I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16280187 ↗
• MalfunctionJun 17, 2022Material Fragmentation; Material Fragmentation

  ON (B)(6) 2022, DIXI MEDICAL USA NOTIFIED DIXI MEDICAL OF A CUSTOMER COMPLAINT FROM CLEVELAND CLINIC (COMPLAINT (B)(4)). THE COMPLAINT IS RELATED TO THE KIP-ACS-600 DURA ELECTRODE DEVICE (LOT NUMBER 204244-09/21) WITH A BREAKAGE OF ITS INSULATING PART AT THE DISTAL END OF THE PRODUCT. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS SENT TO US CONCERNING THE FACT THAT THE CERAMIC PIECE HAS PENETRATED INSIDE THE CRANIAL BOX AND A NEW SURGERY IS REQUIRED TO REMOVE IT. THIS NEW INFORMATION LED TO THE DECISION TO REPORT THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14727314 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170959. One submission often covers many models, so check the product and lot details in each record.

• Z-0534-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0535-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0541-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0537-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0542-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0536-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0539-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0540-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro
• Z-0538-2022 · Dec 9, 2021 · Terminated
  The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electro