Single Use Electrosurgical Knife KD-612 KD-612L (REF N4468940)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170453922), received between Jul 10, 2023 and Oct 2, 2024 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE DERIVATION AND EXTERNAL VALIDATION OF A FIBROSIS RISK MODEL FOR COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THIS STUDY AIMED TO DERIVE AND VALIDATE A PREDICTION MODEL TO DETERMINE THE PREOPERATIVE DEGREE OF SUBMUCOSAL FIBROSIS IN COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 309 PATIENTS (AGE: 68 ± 10.9 YEARS) UNDERWENT COLORECTAL ESD. NO FIBROSIS (F0), F1 FIBROSIS, AND F2 FIBROSIS WERE REPORTED IN 196 (63.4%), 70 (22.6%), AND 43 (13.9%) CASES, RESPECTIVELY. COMPLICATIONS WERE EXPERIENCED IN 20 (6.4%) RESECTIONS, 10 (3.2%) BEING PERFORATIONS AND 10 (3.2%) SIGNIFICANT BLEEDING. AFTER DISSECTION, HEMOSTASIS WAS PERFORMED WITH A COAGRASPER WHENEVER NECESSARY, AND DEFECTS WERE CLOSED WITH THROUGH-THE-SCOPE CLIPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION/10 PATIENTS. SIGNIFICANT BLEEDING/10 PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20351619 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED, THAT DURING THE ESD (ENDOSCOPIC SUBMUCOSAL DISSECTION) PROCEDURE, THE ELECTROSURGICAL KNIFE KD-612 INSULATING CHIP AT THE TIP FELL OFF INSIDE THE BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841276 ↗
• MalfunctionFeb 20, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL INTO THE PATIENT'S BODY. THE ISSUE OCCURRED ABOUT 30 MINUTES AFTER THE START OF A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN INDICATED THE FALLEN PART WOULD BE DISCHARGED NATURALLY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18736995 ↗
• InjuryFeb 7, 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 "ENDOSCOPIC RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER RETROSPECTIVE STUDY (WITH A VIDEO)." THE STUDY WAS TO ELUCIDATE THE CURRENT SCENARIO OF ENDOSCOPIC RESECTION (ER) FOR GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL (B)(6) 2020. THERE WAS 117 PATIENTS WITH 118 LESIONS ENROLLED IN THE STUDY. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. ACCORDING TO THE JAPANESE GUIDELINES FOR THE TREATMENT OF GASTROINTESTINAL STROMAL TUMORS (GISTS) THE FOLLOWING ARE INDICATED FOR RESECTION: 1) HISTOLOGICALLY DIAGNOSED AS GIST. 2) >5 CM. 3) TENDENCY TO ENLARGE. 4) MALIGNANT FINDINGS. IT KNIFE, IT KNIFE 2, OR IT KNIFE NANO (KD-610L, KD-611L, OR KD-612, OLYMPUS, TOKYO, JAPAN) AND NEEDLE SCALPELS WERE USED IN 71 CASES (61%). ADVERSE EVENTS: TWO PATIENTS HAD POSTOPERATIVE BLEEDING THAT WAS STOPPED ENDOSCOPICALLY AND ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICUL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum

  MAUDE report 18660289 ↗
• DeathFeb 7, 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 "ENDOSCOPIC RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER RETROSPECTIVE STUDY (WITH A VIDEO)." THE STUDY WAS TO ELUCIDATE THE CURRENT SCENARIO OF ENDOSCOPIC RESECTION (ER) FOR GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL AUGUST 2020. THERE WAS 117 PATIENTS WITH 118 LESIONS ENROLLED IN THE STUDY. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. ACCORDING TO THE JAPANESE GUIDELINES FOR THE TREATMENT OF GASTROINTESTINAL STROMAL TUMORS (GISTS) THE FOLLOWING ARE INDICATED FOR RESECTION: 1) HISTOLOGICALLY DIAGNOSED AS GIST 2) >5 CM 3) TENDENCY TO ENLARGE 4) MALIGNANT FINDINGS. IT KNIFE, IT KNIFE 2, OR IT KNIFE NANO (KD-610L, KD-611L, OR KD-612, OLYMPUS, TOKYO, JAPAN) AND NEEDLE SCALPELS WERE USED IN 71 CASES (61%). ADVERSE EVENTS: TWO PATIENTS HAD POSTOPERATIVE BLEEDING THAT WAS STOPPED ENDOSCOPICALLY AND ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICULTY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660227 ↗
• MalfunctionFeb 6, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THE FALLEN PART WAS COLLECTED AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648642 ↗
• InjurySep 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE BREAKING OFF CAUSED A MINOR 15-MINUTE DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA WHICH HAD NO NEGATIVE IMPACT ON THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SECOND SINGLE USE ELECTROSURGICAL KNIFE. THE PATIENT WAS DISCHARGED AS PLANNED WITH NO EXTENDED HOSPITAL STAY AS A RESULT OF THE DEVICE MALFUNCTION, AND WAS REPORTED TO BE IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821710 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "DIAGNOSTIC AND THERAPEUTIC STRATEGIES FOR COLORECTAL TUMOR WITH POSITIVE MUSCLE-RETRACTING SIGN." LITERATURE SUMMARY: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR COLORECTAL TUMORS WITH POSITIVE MUSCLE-RETRACTING (MR) SIGN OFTEN RESULTS IN INCOMPLETE RESECTION OR DISCONTINUATION OWING TO THE DIFFICULTY OF SUBMUCOSAL DISSECTION. THE PRESENT STUDY AIMED TO EVALUATE THE USEFULNESS OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) IN DIAGNOSING THE MR SIGN AND PERFORMING ESD USING THE POCKET-CREATION METHOD (PCM). THIRTY-SIX CASES OF COLORECTAL TUMORS WITH POSITIVE MR SIGN DURING ESD BETWEEN (B)(6) 2015 AND (B)(6) 2021 WERE RETROSPECTIVELY REVIEWED. CASES WERE DIVIDED INTO TWO GROUPS: 1) THE CONVENTIONAL METHOD (CM) GROUP, COMPRISING 29 CASES, AND 2) THE PCM GROUP WITH SEVEN CASES, IN WHICH PREOPERATIVE EUS AND ESD USING PCM WERE PERFORMED. TREATMENT OUTCOMES WERE COMPARED BETWEEN THE GROUPS. THE DIAGNOSTIC YIELD OF EUS FOR THE MR SIGN WAS EVALUATED AMONG LARGE SESSILE TUMORS >20 MM IN WHICH PREOPERATIVE EUS WAS PERFORMED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE PERFORATION REQUIRING CLIPS TO CLOSE - 10 PATIENTS. DELAYED PERFORATION ¿

  Patient problems: Bowel Perforation

  MAUDE report 17748780 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS FURTHER RECEIVED INFORMATION FROM THE AUTHOR THAT THE EVENT WAS NOT CAUSED BY AN OLYMPUS DEVICE AND THERE WAS NO MALFUNCTION OBSERVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 17292354 ↗