Single Use Electrosurgical Knife KD-620QR (UDI 04953170251504)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170251504), received between Oct 10, 2018 and Jun 4, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "CLINICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR ESOPHAGEAL SQUAMOUS CELL CARCINOMA WITH ESOPHAGEAL VARICES: MULTICENTER RETROSPECTIVE STUDY." A RETROSPECTIVE COHORT OF 30 PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) COMPLICATING ESOPHAGEAL VARICES (EVS), WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AT ELEVEN JAPANESE INSTITUTIONS. (TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS) UNCONTROLLED INTRAOPERATIVE BLEEDING (1) ESD WAS DISCONTINUED DUE TO UNCONTROLLED INTRAOPERATIVE BLEEDING. ESOPHAGEAL STRICTURE (1) THE STRICTURE WAS RESOLVED WITH ENDOSCOPIC BALLOON DILATION. DEATH (6) NO PATIENT EXPERIENCED SURGICAL TREATMENT, PROCEDURE-RELATED DEATH, OR ESCC-RELATED DEATH.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stenosis of the esophagus

  MAUDE report 19465097 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR OF THE STUDY PROVIDED ADDITIONAL INFORMATION INDICATING NO OLYMPUS DEVICE MALFUNCTIONED DURING ANY PROCEDURE REPORTED IN THE STUDY, AND NO OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO ANY ADVERSE EVENTS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Internal Organ Perforation

  MAUDE report 17409638 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR ANASTOMOTIC LESIONS AFTER COLORECTAL SURGERY." ABSTRACT BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR ANASTOMOTIC LESIONS IS TECHNICALLY CHALLENGING. WE AIMED TO CHARACTERIZE THE CLINICOPATHOLOGIC CHARACTERISTICS, FEASIBILITY, AND EFFECTIVENESS OF ESD FOR ANASTOMOTIC LESIONS OF THE LOWER GASTROINTESTINAL TRACT. METHOD: WE RETROSPECTIVELY INVESTIGATED 55 PATIENTS WITH ANASTOMOTIC LESIONS OF THE LOWER GASTROINTESTINAL TRACT WHO UNDERWENT ESD FROM FEBRUARY 2008 TO JANUARY 2021. THE LESIONS INVOLVING ONE OR BOTH SIDES OF ANASTOMOSES WERE CLASSIFIED INTO THE UNILATERALLY INVOLVING ANASTOMOSIS (UIA) OR STRADDLING ANASTOMOSIS (SA) GROUP, RESPECTIVELY. WE COLLECTED CLINICOPATHOLOGICAL CHARACTERISTICS, PROCEDURE-RELATED PARAMETERS AND OUTCOMES, AND FOLLOW-UP DATA AND ANALYZED THE IMPACT OF ANASTOMOTIC INVOLVEMENT. RESULTS: THE MEAN AGE WAS 62.5 YEARS, AND THE MEDIAN PROCEDURE DURATION WAS 30 MIN. THE RATES OF EN BLOC RESECTION AND R0 RESECTION WERE 90.9% AND 85.5%, RESPECTIVELY. FOUR PATIENTS (7.3%) EXPERIENCED MAJOR ADVERSE EVENTS (AES). DURING A MEDIAN FOLLOW-UP OF 66 MONTHS (RANGE 14¿169), SEV

  Patient problems: Fever; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 17175882 ↗
• MalfunctionOct 10, 2018Break; Break

  DURING AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IT WAS REPORTED THAT THE USER COULD NOT EXTEND THE CUTTING KNIFE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2018, IT WAS FOUND THAT THE TIP OF THE CUTTING KNIFE WAS BROKEN OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7950830 ↗