ELECTROSURGICAL KNIFE KD-1L-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170037702), received between Nov 12, 2020 and Aug 8, 2023 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR, WHO CONFIRMED THAT THE ADVERSE EVENTS WERE NOT CAUSED BY AN OLYMPUS DEVICE AND THAT THERE WAS NO MALFUNCTION OF ANY OLYMPUS DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17484755 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "USEFULNESS OF THE CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION OF GASTRIC NEOPLASIA: A RANDOMIZED CONTROLLED TRIAL". THIS MULTICENTER, RANDOMIZED CONTROLLED TRIAL AIMED TO ASSESS THE EFFICACY OF CLIP-AND-SNARE METHOD USING THE PRE-LOOPING TECHNIQUE (CSM-PLT) IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 378 PATIENTS WERE FINALLY INCLUDED IN THE PER-PROTOCOL ANALYSIS. THE MEAN PROCEDURE TIMES WERE 69.7 AND 58.0 MIN FOR THE CONVENTIONAL ESD AND CSM-PLT GROUPS, INDICATING THAT THE PROCEDURE WAS SIGNIFICANTLY SHORTER IN THE CSM-PLT GROUP (P=0.009). THE R0 RESECTION RATE TENDED TO BE HIGHER IN THE CSM PLT GROUP THAN IN THE CONVENTIONAL ESD GROUP (P=0.09). THE MEAN PROCEDURE TIME WAS SIGNIFICANTLY SHORTER IN THE NOVICE (P=0.04), TUMOR SIZE =20 MM (P=0.02), AND IT KNIFE (P=0.045) GROUPS. THE MEAN PREPARATION TIME FOR CSM-PLT WAS 2.3 MIN. CSM-PLT METHOD SHORTENED THE ESD PROCEDURE TIME. MOREOVER, CSM-PLT IS SAFE, DOES NOT INCREASE COMPLICATION RATES, AND IS ASSOCIATED WITH BETTER R0 RESECTION RATES THAN CONVENTIONAL ESD. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PERFORATION - 5

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16917978 ↗
• InjuryApr 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "RANDOMIZED STUDY OF TWO ENDO-KNIVES FOR THE TRACTION-ASSISTED ENDOSCOPIC SUBMUCOSAL DISSECTION OF EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA" BY YOSHIYASU KITAGAWA, ET AL. ABSTRACT: NEEDLE-TYPE DEVICES, SUCH AS THE DUALKNIFE (OLYMPUS, TOKYO, JAPAN), ARE WIDELY USED FOR TRACTION-ASSISTED ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BUT REQUIRE A PROLONGED OPERATION TIME. AN IMPROVED MODEL OF THE ITKNIFE (OLYMPUS), THE ITKNIFE NANO, MAY ALLOW FASTER AND EASIER ESD THAN THE DUALKNIFE. WE CONDUCTED A RANDOMIZED STUDY TO COMPARE THE PERFORMANCES OF THE DUALKNIFE AND THE ITKNIFE NANO FOR TRACTION-ASSISTED ESOPHAGEAL ESD. PATIENTS WITH EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA WERE ELIGIBLE FOR THIS STUDY. THE PRIMARY OUTCOME WAS THE TOTAL PROCEDURE TIME. THE SECONDARY OUTCOMES WERE SUBMUCOSAL DISSECTION TIME, EN BLOC, AND COMPLETE RESECTION RATES, PERFORATION RATE, AND ADVERSE EVENTS. RESULTS FIFTY PATIENTS WERE EQUALLY DIVIDED INTO TWO GROUPS: THE DUALKNIFE GROUP (D-GROUP) AND THE ITKNIFE NANO GROUP (I-GROUP), AND ALL UNDERWENT THE ASSIGNED TREATMENT. THE I-GROUP HAD SIGNIFICANTLY SHORTER TOTAL PROCEDURE TIME (36.8 VS. 60.7 MIN; P0.01) AND S

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 14170770 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING ARTICLE: "DETECTION OF SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL NEOPLASIA BY CHROMOENDOSCOPY-GUIDED CONFOCAL LASER ENDOMICROSCOPY" BY JIN HUANG, YUN-SHENG YANG, ZHONG-SHENG LU, ET AL. THE SINGLE-CENTER STUDY WAS AIMED TO DETERMINE THE DIAGNOSTIC POTENTIAL OF CONFOCAL LASER ENDOMICROSCOPY (CLE) COMBINED WITH LUGOL'S IODINE CHROMOENDOSCOPY (LIC) IN DETECTING SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL NEOPLASIA (ESCN) USING A HISTOLOGICAL EXAMINATION OF EN BLOC ENDOSCOPIC RESECTION (ER) SPECIMENS AS THE STANDARD. THE LIC-CLE WAS PERFORMED IN 52 ENROLLED PATIENTS. IN THE SAME PATIENTS, A CHROMOENDOSCOPY-GUIDED BIOPSY WAS PERFORMED BY ANOTHER ENDOSCOPIST, AND THEY WERE COMPARED FOR THE DETECTION RATES. THE REPORTED SENSITIVITY, SPECIFICITY, NEGATIVE PREDICTIVE VALUE, AND POSITIVE PREDICTIVE VALUE OF CHROMOENDOSCOPY-GUIDED CLE WERE 95.7%, 90%, 81.8%, AND 97.8%, RESPECTIVELY. IN CONCLUSION, THE STUDY DEMONSTRATED THAT ESCN COULD BE DIAGNOSED RELIABLY BY LIC-CLE. A TOTAL OF 56 LESIONS IN 52 PATIENTS WERE ENROLLED FOR THE STUDY, INCLUDING 16 FEMALES AND 36 MALES (MEAN AGE, 60.5 YEARS; RANGE, 43-78 YEARS). THE AUTHORS USED MULTIPLE OLYMPUS DEVICES AND DID NOT SPECIFY THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 13653077 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 2, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "PERIOPERATIVE COMPLICATIONS OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR EARLY GASTRIC CANCER IN ELDERLY JAPANESE PATIENTS 75 YEARS OF AGE OR OLDER". THIS STUDY WAS CONDUCTED THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR EARLY GASTRIC CANCER ON 307 PATIENTS BETWEEN APRIL 2004 AND MARCH 2009. THE ESDS WERE PERFORMED BY THE SUBJECT DEVICE. IN THE LITERATURE, IT WAS REPORTED THAT 26 CASES OF BRADYCARDIA, 8 CASES OF PERFORATION, AND ONE SEVERE BLEEDING HAVE OCCURRED. THE PATIENTS WITH BRADYCARDIA WERE TREATED WITH ADMINISTRATION OF ATROATROPINE. THE PATIENTS OF PERFORATION WERE SUCCESSFULLY TREATED WITH CLIPPING, AND THE ESD PROCEDURE WAS COMPLETED IN ALL CASES. MEANWHILE, ONE PATIENT OF SEVERE BLEEDING RESULTED IN THE DISCONTINUATION OF ESD. BASED ON THE AVAILABLE INFORMATION, DETAILED INFORMATION OF THE SUBJECT DEVICE WAS NOT PROVIDED, AND THERE IS NO DESCRIPTION OF THE RELATIONSHIP BETWEEN THE EVENTS AND THE SUBJECT DEVICE. HOWEVER, OMSC ASSUMES THAT SEVERE BLEEDING MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR SUBMUCOSAL RESECTION. THEREFORE OMSC ASSUMES THAT THE SEVERE

  Patient problems: Blood Loss

  MAUDE report 10827381 ↗