Single Use Electrosurgical Knife KD-655 KD-655U (UDI 04953170377532)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170377532), received between Feb 11, 2022 and Aug 31, 2026 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Fracture

  The customer returned the Single Use Electrosurgical Knife to the Investigation center for a separate issue. During the device analysis, the investigator indicated that the knife head was fractured. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50524240 ↗
• MalfunctionAug 31, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50521967 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944091 ↗
• MalfunctionMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP ON THE ELECTROSURGICAL KNIFE FELL OFF. THE REPORTED ISSUE WAS DISCOVERED DURING A THERAPEUTIC PROCEDURE WHEN THE KNIFE WAS REMOVED FROM THE WORKING CHANNEL. THE KNIFE WAS SET ASIDE AND A NEW KNIFE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21943898 ↗
• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "CLINICAL AUDIT OF ENDOSCOPIC SUB-MUCOSAL DISSECTION PERFORMED FOR COMPLEX LATERAL SPREADING COLORECTAL TUMORS FROM A REGION NON-ENDEMIC FOR COLORECTAL CANCER." LITERATURE SUMMARY: BACKGROUND ENDOSCOPIC RESECTION IS CURRENTLY THE TREATMENT OF CHOICE FOR LATERALLY SPREADING TUMORS (LSTS). ENDOSCOPIC SUB-MUCOSAL DISSECTION (ESD) CAN ACHIEVE HIGHER ENBLOC RESECTION AND R0 RESECTION, ALBEIT AT A SLIGHTLY HIGHER RISK OF COMPLICATIONS. GIVEN SCARCE DATA ON ESD FROM INDIA, WE PERFORMED A RETROSPECTIVE ANALYSIS OF OUR EXPERIENCE WITH COLORECTAL ESD (CR-ESD) TO KNOW ITS CLINICAL EFFICACY AND COMPLICATIONS AS WELL AS TO ASSESS THE LEARNING CURVE OF CR-ESD IN NON-ENDEMIC-AREAS. METHODS RETROSPECTIVE ANALYSIS OF PROSPECTIVELY MAINTAINED DATASHEET PERFORMED. ALL PATIENTS WITH LARGE (>2CM), COMPLEX OR RECURRENT COLORECTAL LST WHO UNDERWENT ESD AT OUR CENTER BETWEEN 2012 AND 2021 WERE INCLUDED IN THE STUDY. VARIOUS BASELINE LESION-RELATED PARAMETERS, PROCEDURE-RELATED PARAMETERS, ENBLOC RESECTION (ER) RATES, R0 MARGINS AND ADVERSE EVENT RATES WERE RETRIEVED. CUSUM ANALYSIS WAS PERFORMED TO CALCULATE THE MINIMUM REQUIRED PROCEDURES

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

  MAUDE report 20844220 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833344 ↗
• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE DETACHED FROM THE DISTAL PART OF THE SCALPEL. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, WHILE THE DEVICE WAS INSIDE THE PATIENT. THERE WAS A PROCEDURAL DELAY UNDER 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833273 ↗
• MalfunctionAug 8, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE BROKE OFF. THE ISSUE OCCURRED DURING UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939173 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE BROKE OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911744 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THE SINGLE USE ELECTROSURGICAL KNIFE BROKE OFF. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19910830 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE ELECTROSURGICAL CUTTING KNIFE TIP WAS BROKEN AND MISSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825849 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALTHOUGH ADDITIONAL INFORMATION WAS REQUESTED, THE AUTHOR REPORTED THAT THERE WAS "NO MENTION AT ALL OF AN OLYMPUS DEVICE" IN THE LITERATURE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19163876 ↗
• MalfunctionFeb 26, 2024Break; Break

  IT WAS REPORTED THAT THE DISTAL END OF THE SINGLE USE ELECTROSURGICAL KNIFE BROKE OFF DURING THE THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778771 ↗
• InjuryJan 13, 2023Dull, Blunt; Dull, Blunt

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ELECTROSURGICAL KNIFE WAS UNABLE TO CUT PROPERLY AND DIFFICULTY WITH INJECTION WAS OBSERVED DURING A SUBMUCOSAL DISSECTION. A SIMILAR DEVICE WAS USED AS REPLACEMENT, BUT THE SAME ISSUES WERE OBSERVED. CONSEQUENTLY, A FRAGMENTED MUCOSECTOMY HAD TO BE PERFORMED INSTEAD. AS A RESULT, THE PATIENT REQUIRED A COLONOSCOPY IN 3 TO 6 MONTHS INSTEAD OF 3 TO 6 YEARS. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE INITIAL ELECTROSURGICAL KNIFE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE REPLACEMENT ELECTROSURGICAL KNIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16160711 ↗
• InjuryJan 13, 2023Dull, Blunt; Dull, Blunt

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ELECTROSURGICAL KNIFE WAS UNABLE TO CUT PROPERLY AND DIFFICULTY WITH INJECTION WAS OBSERVED DURING A SUBMUCOSAL DISSECTION. A SIMILAR DEVICE WAS USED AS REPLACEMENT, BUT THE SAME ISSUES WERE OBSERVED. CONSEQUENTLY, A FRAGMENTED MUCOSECTOMY HAD TO BE PERFORMED INSTEAD. AS A RESULT, THE PATIENT REQUIRED A COLONOSCOPY IN 3 TO 6 MONTHS INSTEAD OF 3 TO 6 YEARS. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED DUE TO THE EVENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE INITIAL ELECTROSURGICAL KNIFE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE REPLACEMENT ELECTROSURGICAL KNIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16160090 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "ENDOSCOPIC FULL-THICKNESS RESECTION VERSUS ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF COLONIC NEOPLASTIC LESIONS = 30 MM¿A SINGLE-CENTER EXPERIENCE."    LITERATURE SUMMARY. THE PURPOSE OF THE ANALYSIS WAS TO EVALUATE EFFICACY AND SAFETY OF FULL-THICKNESS RESECTION (FTR) IN THE TREATMENT OF COLORECTAL LESIONS = 30 MM BY COMPARING PROSPECTIVELY FOLLOWED FTR COHORT TO RETROSPECTIVE SUBMUCOSAL DISSECTION (ESD) COHORT IN THE SETTING OF SINGLE TERTIARY ENDOSCOPY CENTER. PRIMARY OUTCOMES WERE TECHNICAL SUCCESS RATE, R0 RESECTION AND CURATIVE RESECTION RATE, AND COMPLICATION RATE. A TOTAL OF 52 PATIENTS IN FTR AND 50 PATIENTS IN ESD GROUP WERE TREATED BETWEEN 2015 AND 2018. TECHNICAL SUCCESS RATE WAS SIGNIFICANTLY HIGHER IN FTR GROUP (92 VS. 74%, P = 0.01) AS WELL AS R0 RESECTION RATE (85 VS. 62%, P = 0.01) AND CURATIVE RESECTION RATE (75 VS. 56%, P = 0.01). COMPLICATIONS OCCURRED MORE FREQUENTLY IN ESD GROUP (40 VS. 13%, P = 0.002), MAINLY DUE TO HIGH INCIDENCE OF ELECTROCOAGULATION SYNDROME (24 VS. 0%). TOTAL PROCEDURE TIME WAS SUBSTANTIALLY SHORTER IN FTR GROUP (26.4 ± 11.0 MIN VS. ESTIMATED 90¿240 MIN). LOCAL RESIDUAL NEOPLASTIC LES

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14856900 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED: "MANAGEMENT OF GASTROINTESTINAL SUBEPITHELIAL TUMORS WITH ENDOSCOPIC RESECTION." LITERATURE SUMMARY: THIS STUDY WAS CONDUCTED TO EXPLAIN THE MANAGEMENT OF GASTROINTESTINAL SUBEPITHELIAL TUMORS (GI SETS) AND RESECTING GI SETS WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER) TO EXPLORE THE EFFICACY OF THIS TECHNIQUE. A TOTAL OF 39 PATIENTS WERE INVOLVED IN THIS STUDY. OUT OF THEM 36 WERE RESECTED BY ESD AND 3 WERE RESECTED BY STER. THE SURGICAL METHODS ESD AND STER WERE CONDUCTED USING THE DEVICE ENDOSCOPE GIFQ260J, DISTAL HOOD D-201-11 304, ELECTROCOAGULATION UNIT ESG 100, DUAL KNIFE, DUAL KNIFE J, IT KNIFE NANO AND OTHER DEVICES. THE MEAN TUMOR SIZE WAS 16.8 ± 1.3 MM. THE OVERALL PROCEDURAL TIME WAS 37.9 ± 4.6 MINUTES. COMPLICATIONS LIKE PERFORATIONS WERE OBSERVED IN THREE PATIENTS. THE STUDY CONCLUDED THAT ESD AND STER CAN BE AN EFFECTIVE MODALITY FOR THE DIAGNOSIS AND MANAGEMENT OF GI SETS IN A SELECTED GROUP OF PATIENTS. THE AUTHORS REPORTED MILD PAIN AFTER ESD, UNSPECIFIED BLEEDING AND UNSPECIFIED INFECTION. THE REPORTABLE EVENTS IDENTIFIED BY THE AUTHOR ARE: PERFORATION -(N=3), SU

  Patient problems: Perforation; Unspecified Respiratory Problem

  MAUDE report 14471996 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: SINGLE OPERATOR EXPERIENCE OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR BARRETT'S NEOPLASIA IN A NORTH AMERICAN ACADEMIC CENTER BY DOUGLAS MOTOMURA ROBERT BECHARA. ABSTRACT: OBJECTIVES: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) IS CARVING OUT AN INCREASING ROLE IN THE TREATMENT OF BARRETT'S ASSOCIATED NEOPLASIA. ESD PROVIDES THE ADVANTAGE OF EN-BLOC RESECTIONS AND GREATER RO RESECTION RATES. WE AIM TO PRESENT OUTCOMES FROM ONE OF THE LARGEST SINGLE-CENTER COHORTS OF ESOPHAGEAL ESD IN NORTH AMERICA. METHODS: ALL PATIENTS UNDERGOING ESOPHAGEAL ESD FOR BARRETT'S NEOPLASIA BETWEEN OCT 2016 AND JUNE 2020 AT A CANADIAN TERTIARY CARE CENTER WERE INCLUDED. DEMOGRAPHIC, PROCEDURAL DATA, AND LESION CHARACTERISTICS ARE PRESENTED. SUBGROUP ANALYSIS WAS PERFORMED ON PATIENTS WHO UNDERWENT EXTENSIVE RESECTION (>75% OF ESOPHAGEAL CIRCUMFERENCE) AND THE PATIENTS WHO DEVELOPED STRICTURES. RESULTS: THIRTY-FOUR PATIENTS WERE INCLUDED IN THE SERIES. THE MEDIAN LESION DIAMETER WAS 5.7 CM AND THE MEDIAN PROCEDURE TIME WAS 129 MIN. THE ENBLOC RESECTION RATE WAS 97%, AND THE RO RESECTION RATE WAS 91%. CURATIVE RESECTION WAS ACHIEVED IN 82% OF PATIENTS. UPSTAGING IN HISTO

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

  MAUDE report 13516243 ↗