Single Use Electrosurgical Knife KD-655 KD-655L (UDI 04953170377488)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170377488), received between Dec 15, 2023 and Dec 15, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fire” (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

Recent adverse event reports

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

• InjuryDec 15, 2023Fire; Fire

  THE CUSTOMER REPORTED THAT WHEN USING AN EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE, THERE WAS FIRE AT THE PLASTIC DISTAL END COVER CAUSING BURNS TO THE PATIENT¿S STOMACH. THE EVENT OCCURRED DURING THE PRE-LABELING PHASE OF A THERAPEUTIC PROCEDURE (ESD) AND THE C02 AIR PUMP WAS USED TO SUPPLY THE GAS AT THE TIME OF THE INCIDENT. THERE WAS NO PROCEDURAL DELAY, OR NO FURTHER PATIENT HARM REPORTED WITH THE EVENT. THE PROCEDURE WAS FINISHED WITH ANOTHER SET OF DEVICE. THE PATIENT WAS HOSPITALIZED FOR FURTHER TREATMENT. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT NOT RECEIVED AT THIS TIME. THIS EVENT REQUIRES THREE REPORTS, AS ALL DEVICES WERE USED DURING THE EVENT: PATIENT IDENTIFIER (B)(6) IS FOR THE VIDEOSCOPE. PATIENT IDENTIFIER (B)(6) IS FOR THE ELECTROSURGICAL KNIFE. PATIENT IDENTIFIER C23555710 IS FOR THE HF UNIT

  Patient problems: Burn(s)

  MAUDE report 18336057 ↗