Fixed Tip Electrode, J-Hook ES3510BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10815288010415), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K912780); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionDec 17, 2025Fracture; Material Separation; Fracture; Material Separation

  DURING A LAPAROSCOPIC PROCEDURE, THE TIP OF THE PRIMARY ULTEM INSULATION CRACKED FROM THE J-HOOK FIXED-TIP ELECTRODE AND FELL INTO THE PATIENT. THE TWO PIECES OF THE INSULATION WERE RECOVERED. NO INJURY OR DEATH WAS REPORTED. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K912780. One submission often covers many models, so check the product and lot details in each record.

• Z-2397-2011 · Apr 7, 2011 · Terminated
  ES0110, AEM Disposable Hook Scissors, 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2398-2011 · Apr 7, 2011 · Terminated
  ES0120, AEM Disposable Low Profile Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2395-2011 · Apr 7, 2011 · Terminated
  ES0101, AEM Disposable Curved Scissors, 1/2", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2396-2011 · Apr 7, 2011 · Terminated
  ES0102, AEM Disposable Curved Scissors, 3/4", 35cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2399-2011 · Apr 7, 2011 · Terminated
  ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-2400-2011 · Apr 7, 2011 · Terminated
  ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301 Cutting tissue during electrosurgical procedures
• Z-1074-04 · Jun 11, 2004 · Terminated
  AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
• Z-0470-03 · Jan 15, 2003 · Terminated
  AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B