Single Use Electrosurgical Knife KD-625 KD-625QRRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170407833), received between Feb 7, 2024 and Mar 6, 2024 — classified as 2 malfunctions.

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

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

• MalfunctionMar 6, 2024Break; Break

  THE CUSTOMER REPORTED THE ENERGIZING PART OF THE ELECTROSURGICAL KNIFE BROKE OFF FROM THE SHEATH WHEN ENERGIZED FOR THE FIRST TIME. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE IN THE LARGE INTESTINE. THE FALLEN PARTS WERE NOT COLLECTED AND WOULD BE NATURALLY DISCHARGED. THERE WAS NO SENSE OF INCONGRUITY AT THE TIME OF INSPECTION PRIOR TO AND DURING USE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845926 ↗
• MalfunctionFeb 7, 2024Break; Break

  THE CUSTOMER REPORTED THE INCISION KNIFE PART AT THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF AFTER ENERGIZING SEVERAL TIME. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE OF THE LARGE INTESTINES. THE PART THAT FELL OFF WAS LEFT IN THE LARGE INTESTINES TO BE NATURALLY DISCHARGED FROM THE BODY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18657590 ↗