Single Use Electrosurgical Knife KD-612 KD-612URecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170325939), received between May 23, 2022 and Nov 13, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "BALLOON-ASSISTED ENTEROSCOPY-BASED ENDOSCOPIC STRICTUROTOMY FOR DEEP SMALL BOWEL STRICTURES FROM CROHN'S DISEASE: FIRST COHORT STUDY OF A NOVEL APPROACH". LITERATURE SUMMARY: BACKGROUND: THERE IS LITTLE DATA ON THE ROLE OF ENDOSCOPIC STRICTUROTOMY (ES) IN TREATING DEEP SMALL BOWEL STRICTURES. WE AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF BALLOON-ASSISTED ENTEROSCOPY-BASED ES (BAE- BASED ES) FOR DEEP SMALL BOWEL STRICTURES ASSOCIATED WITH CROHN¿S DISEASE (CD). METHODS: THIS MULTICENTRE RETROSPECTIVE COHORT STUDY INCLUDED CONSECUTIVE PATIENTS WITH CD-ASSOCIATED DEEP SMALL BOWEL STRICTURES TREATED WITH BAE-BASED ES BETWEEN 2017 AND 2023. THE OUTCOMES INCLUDED TECHNICAL SUCCESS, CLINICAL IMPROVEMENT, SURGERY-FREE RATE, REINTERVENTION-FREE RATE, AND ADVERSE EVENTS. RESULTS: TWENTY-EIGHT PATIENTS WITH CD UNDERWENT 58 BAE-BASED ES PROCEDURES FOR NON-PASSABLE DEEP SMALL BOWEL STRICTURES, WITH A MEDIAN FOLLOW-UP TIME OF 519.5 DAYS (INTERQUARTILE RANGE, 306¿728 DAYS). FIFTY-SIX (96.0%) PROCEDURES WERE TECHNICALLY SUCCESSFUL IN 26 (92.9%) PATIENTS. TWENTY PATIENTS (71.4%) SHOWED CLINICAL IMPROVEMENT AT WEEK 8. THE CUMULAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18123261 ↗
• InjuryOct 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE TERRITORY MANAGER REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A THERAPEUTIC, PERORAL ENDOSCOPIC MYOTOMY PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE BROKE AND FELL INSIDE THE PATIENT BODY AND BROKEN TIP WAS RETRIEVED. THERE WAS NO MEDICAL INTERVENTION REQUIRED OTHER THAN THE RETRIEVAL OF THE FALLEN DEVICE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH A DELAY OF AROUND 30 MINUTES. FURTHER FOLLOW-UP WITH THE CUSTOMER HAS BEEN CONDUCTED BUT ADDITIONAL INFORMATION IS UNAVAILABLE AT THE TIME OF THIS REPORT. NO PATIENT INJURY OR HARM REPORTED. THE DEVICE WAS INSPECTED PRIOR TO USE OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986350 ↗
• 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."     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). SUBCUTANEOUS EMPHY

  Patient problems: Perforation; Unspecified Respiratory Problem

  MAUDE report 14471963 ↗