Single Use Electrosurgical Knife KD-620LR (REF N1080340)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170453946), received between Oct 16, 2023 and Nov 21, 2024 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER AN UNSPECIFIED SURGERY, THE TIP OF THE KNIFE WIRE FELL OFF INTO THE PATIENT'S BODY AND WAS RETRIEVED. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO REPORTS OF ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745778 ↗
• InjuryNov 6, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE, TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE BROKE OFF DURING ESD ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE AND FELL INTO THE PATIENT¿S BODY AND FELL INTO THE PATIENT'S STOMACH. THE FALLEN KNIFE WAS RETRIEVED USING GRASPING FORCEPS. THE PROCEDURE WAS COMPLETED AFTER REPLACING IT WITH A SIMILAR DEVICE. NO HEALTH DAMAGE TO THE PATIENT OCCURRED. THE PROCEDURE WAS NOT DELAYED, AND NO ADDITIONAL SEDATION WAS REQUIRED. NO ADDITIONAL PROCEDURE/INTERVENTION WAS UNDERTAKEN. THE PATIENT'S CONDITION IS REPORTED AS "GOOD" AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20617287 ↗
• InjuryOct 28, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF SINGLE USE ELECTROSURGICAL KNIFE BROKE OFF DURING AN UPPER ESD-ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE (INTRAOPERATIVE INSPECTION), AND FELL INTO THE PATIENT'S STOMACH. IT WAS RETRIEVED USING GRASPING FORCEPS. THE DOCTOR REPLACED THE DEVICE WITH ANOTHER PRODUCT OF THE SAME MODEL NUMBER AND COMPLETED THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT AND THE CURRENT CONDITION OF THE PATIENT IS REPORTED AS GOOD. NO ADDITIONAL SEDATION WAS REQUIRED AND NO DELAY REPORTED. NO ADDITIONAL INTERVENTIONS WERE REQUIRED. THERE WERE NO ADVERSE EVENTS OR COMPLICATIONS REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20544625 ↗
• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR WAS ASKED FOR ADDITIONAL INFORMATION, BUT ALL REQUESTED DETAILS WERE UNAVAILABLE.

  Patient problems: Bacterial Infection; Chest Pain; Fever; Hemorrhage/Blood Loss/Bleeding; High White Blood Cell Count

  MAUDE report 20065515 ↗
• InjuryJul 15, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A PROCEDURE, THE PROBE FELL INTO THE PATIENT'S BODY AND WAS RECOVERED, THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746600 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THE ELECTROSURGICAL KNIFE TIP WAS CHIPPED AFTER SEVERAL OUTPUTS DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION. IT WAS NOT CONFIRMED WHETHER THE TIP HAD FALLEN OFF, BUT IT IS POSSIBLE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18927398 ↗
• MalfunctionMar 16, 2024Break; Break

  IT WAS REPORTED, THE SINGLE USE ELECTROSURGICAL KNIFE TIP OF THE HOOK WAS BROKEN. ANOTHER DEVICE WAS USED AND THE SAME PHENOMENON OCCURRED AGAIN. THE ISSUE OCCURRED DURING ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THE TIP WAS NOT RECOVERED. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918966 ↗
• MalfunctionMar 5, 2024Break; Break

  THE CUSTOMER REPORTED THE TOP OF THE ELECTROSURGICAL KNIFE BROKE. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. ANOTHER KNIFE WAS USED AND THE TIP BROKE AGAIN. THE PROCEDURE CONTINUED AS IS AND THE BROKEN TIP WAS NOT RECOVERED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838999 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE DURING THE ENDOSCOPIC SUBMUCOSAL DISSECTION THE TIP WAS CHIPPED AFTER SEVERAL OUTPUTS. THE PROCEDURE WAS COMPLETED AND THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18834558 ↗
• InjuryOct 16, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE OLYMPUS EMPLOYEE REPORTED ON BEHALF OF THE CUSTOMER THAT DURING THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE THE SINGLE USE ELECTROSURGICAL KNIFE FELL INTO THE PATIENT'S ANTRUM AND IT WAS RETRIEVED WITH A PAIR OF FORCEPS BY THE DOCTOR. THE PROCEDURE WAS COMPLETED WITH A SIMILAR EQUIPMENT. NO PATIENT INJURY REPORTED. THE DEVICE WAS INSPECTED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17945368 ↗