PRECUTTING KNIFE KD-10Q-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170038051), received between Aug 1, 2022 and Oct 14, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CORP. (OMSC) RECEIVED A LITERATURE TITLED. "ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY USING A PEDIATRIC COLONOSCOPE IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY AND AN INTACT MAJOR DUODENAL PAPILLA." LITERATURE SUMMARY: THIS STUDY EVALUATED THE EFFICACY OF USING A PEDIATRIC COLONOSCOPE IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY AND AN INTACT MAJOR DUODENAL PAPILLA. A TOTAL OF (B)(4) PATIENTS ((B)(4)) WITH ROUX-EN-Y GASTRECTOMY UNDERWENT ERCP USING A PEDIATRIC COLONOSCOPE. THE SUCCESS RATES OF ENDOSCOPE INSERTION, ENDOSCOPIC CANNULATION, THERAPEUTIC ERCP AND CLINICAL INTERVENTION WERE (B)(4), RESPECTIVELY. THE ENDOSCOPE INSERTION TIME WAS 40.78±10.04 MIN, WHILE THE ERCP PROCEDURE TIME WAS 88.55±16.38 MIN. MATERIALS AND METHODS: PATIENTS. CONSECUTIVE PATIENTS WITH ROUX-EN-Y GASTRECTOMY AND AN INTACT MAJOR DUODENAL PAPILLA WHO UNDERWENT ERCP USING A PEDIATRIC COLONOSCOPE AT THE MEDICAL CENTER FOR DIGESTIVE DISEASES, THE SECOND AFFILIATED HOSPITAL OF (B)(6) ((B)(6) CHINA) BETWEEN (B)(6)2018 AND (B)(6) 2022 WERE RETROSPECTIVELY REVIEWED. PATIENTS WITH COAGULATION DISORDERS, SEVERE CARDIOPULMONARY INSUFFICIENCY AND AGE 18 OR 86 YEARS WERE EXCLUDED. DATA WERE EXTRACTED FROM THE MEDICAL RECORDS

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 20445344 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "COMPARISON OF ANTICOAGULANTS AND RISK FACTORS FOR BLEEDING FOLLOWING ENDOSCOPIC SPHINCTEROTOMY AMONG ANTICOAGULANT USERS: RESULTS FROM A LARGE MULTICENTER RETROSPECTIVE STUDY". BACKGROUND AND AIM BLEEDING IS AN INEVITABLE AND OFTEN SEVERE COMPLICATION AFTER ENDOSCOPIC SPHINCTEROTOMY (EST). WE AIMED TO INVESTIGATE THE FACTORS ASSOCIATED WITH POST-EST BLEEDING IN PATIENTS TREATED WITH ANTICOAGULANTS. METHODS THE DATA OF PATIENTS WHO UNDERWENT EST AT 15 HOSPITALS BETWEEN JULY 2015 AND JUNE 2017 WERE EXTRACTED. WE INVESTIGATED THE INCIDENCE OF POST-EST BLEEDING AND RISK FACTORS FOR BLEEDING IN PATIENTS TREATED WITH ANTICOAGULANTS. RESULTS ONE HUNDRED FORTY-NINE PATIENTS UNDERGOING EST WHO MET THE INCLUSION CRITERIA WERE INCLUDED IN THIS STUDY. THE TOTAL-EST BLEEDING (BLEEDING OCCURRING DURING OR AFTER EST) RATE DID NOT DIFFER BETWEEN THE HEPARIN REPLACEMENT (8.0%, 6/75) AND CONTINUATION (16.6%, 2/12; P = 0.37) GROUPS OF WARFARIN USERS. THE TOTAL-EST-BLEEDING RATE IN THE HEPARIN REPLACEMENT GROUP (12.9%, 4/31) WAS SIGNIFICANTLY HIGHER THAN THAT IN THE CONTINUATION GROUP (0%, 0/31; P = 0.016) IN DIRECT ORAL ANTICOAGULANT (DOAC) USERS. TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16687134 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "BALLOON ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR THE TREATMENT OF COMMON BILE DUCT STONES IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY: OUTCOMES AND FACTORS AFFECTING COMPLETE STONE EXTRACTION." THIS RETROSPECTIVE STUDY INVESTIGATED THE TREATMENT OUTCOMES AND POTENTIAL FACTORS AFFECTING COMPLETE STONE EXTRACTION IN 79 PATIENTS. THE INITIAL SUCCESS RATES OF REACHING THE PAPILLA OF VATER, BILIARY CANNULATION, AND BILIARY INTERVENTION, INCLUDING COMPLETE STONE EXTRACTION OR BILIARY STENT PLACEMENT, WERE 92%, 81%, AND 78%, RESPECTIVELY. THE MULTIVARIATE ANALYSIS INDICATED THAT THE LARGEST CBD DIAMETER = 14 MM (ODDS RATIO (OR), 0.04; 95% CONFIDENCE INTERVAL (CI), 0.01¿0.58) AND RETROFLEX POSITION (OR, 6.43; 95% CI, 1.12¿36.81) WERE INDEPENDENT PREDICTIVE FACTORS AFFECTING COMPLETE STONE EXTRACTION ACHIEVEMENT. THIS STUDY CONCLUDES THAT THERAPEUTIC SDBE-ERCP FOR CBD STONES IN A RELATIVELY ELDERLY RYG COHORT, WAS EFFECTIVE AND SAFE. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. MILD PERFORATION - 1 PATIENT. MODERATE PERFORATION - 1 PATIENT. MILD PANCREATITIS - 1 PATIENT. MILD HYPOXIA - 1 PATIENT. THIS WAS A MULTI-CEN

  Patient problems: Hypoxia; Pancreatitis; Perforation

  MAUDE report 16127835 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  [AUTO-TRANSLATED] CORP. (OMSC) RECEIVED A LITERATURE TITLED. "BALLOON ENTEROSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR THE TREATMENT OF COMMON BILE DUCT STONES IN PATIENTS WITH ROUX-EN-Y GASTRECTOMY: OUTCOMES AND FACTORS AFFECTING COMPLETE STONE EXTRACTION." LITERATURE SUMMARY: THIS RETROSPECTIVE STUDY INVESTIGATED THE TREATMENT OUTCOMES AND POTENTIAL FACTORS AFFECTING COMPLETE STONE EXTRACTION IN 79 PATIENTS. THE INITIAL SUCCESS RATES OF REACHING THE PAPILLA OF VATER, BILIARY CANNULATION, AND BILIARY INTERVENTION, INCLUDING COMPLETE STONE EXTRACTION OR BILIARY STENT PLACEMENT, WERE 92%, 81%, AND 78%, RESPECTIVELY. THE MULTIVARIATE ANALYSIS INDICATED THAT THE LARGEST CBD DIAMETER = 14 MM (ODDS RATIO (OR), 0.04; 95% CONFIDENCE INTERVAL (CI), 0.01¿0.58) AND RETROFLEX POSITION (OR, 6.43; 95% CI, 1.12¿36.81) WERE INDEPENDENT PREDICTIVE FACTORS AFFECTING COMPLETE STONE EXTRACTION ACHIEVEMENT. THIS STUDY CONCLUDES THAT THERAPEUTIC SDBE-ERCP FOR CBD STONES IN A RELATIVELY ELDERLY RYG COHORT, WAS EFFECTIVE AND SAFE. ¿TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS¿ MILD PERFORATION - 1 PATIENT MODERATE PERFORATION - 1 PATIENT MILD PANCREATITIS - 1 PATIENT MILD HYPOXIA - 1

  Patient problems: Hypoxia; Pancreatitis; Perforation

  MAUDE report 16126299 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNDERWATER ENDOSCOPIC SUBMUCOSAL DISSECTION AND HYBRID ENDOSCOPIC SUBMUCOSAL DISSECTION AS RESCUE THERAPY IN DIFFICULT COLORECTAL CASES". THIS RETROSPECTIVE ANALYSIS DEMONSTRATES THAT UNDERWATER ESD (U-ESD) AND HYBRID ESD (H-ESD) ARE BOTH EFFECTIVE AND SAFE AS RESCUE THERAPY IN DIFFICULT COLORECTAL ESD. THERE WERE FIFTY-NINE COLORECTAL NEOPLASMS WERE CONSIDERED, 22 OF WHICH WERE REMOVED BY U-ESD AND 37 BY H-ESD. THE EN BLOC RESECTION RATE IN THE U-ESD GROUP WAS 100 %, WHILE IT WAS 59.5% IN THE H-ESD GROUP. DISSECTION SPEED WAS 17.7MM2/MIN IN THE U-ESD GROUP AND 8.3MM2/MIN IN THE H-ESD GROUP. THIS STUDY CONCLUDES THAT THE U-ESD AND H-ESD ARE BOTH EFFECTIVE AND SAFE TECHNIQUES IN DIFFICULT COLORECTAL SITUATIONS. U-ESD IS PARTICULARLY EFFECTIVE AND FAST FOR LARGE LESIONS WHEN IT IS NOT POSSIBLE TO OBTAIN COMFORTABLE KNIFE POSITION, WHILE H-ESD IS MORE SUITABLE FOR VERY FIBROTIC LESIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [UNDERWATER ESD] BACTEREMIA - 1 PATIENT. [HYBRID ESD]. PERFORATION - 4 PATIENTS. BLEEDING - 4 PATIENTS. BACTEREMIA - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 4 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS

  Patient problems: Bacterial Infection; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16088677 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE "SUCCESS AND SAFETY OF NEEDLE KNIFE PAPILLOTOMY AND FISTULOTOMY BASED ON PAPILLARY ANATOMY: A PROSPECTIVE CONTROLLED TRIAL." LITERATURE SUMMARY: THIS STUDY AIMED TO EVALUATE THE VALIDITY AND SAFETY OF THIS INDIVIDUALIZED THERAPY, THE INITIAL SUCCESS RATE OF BILIARY CANNULATION (ISRBC), AND COMPLICATION RATES OF PATIENTS WHO UNDERWENT NKP AND NKF WERE COMPARED PROSPECTIVELY AMONG DIFFERENT TYPES OF MDPS AND BETWEEN TWO PRECUT APPROACHES. A TOTAL OF 188 OUT OF 1674 PATIENTS UNDERGOING ERCP SATISFIED THE CRITERIA FOR EARLY PRECUTTING: 75 PATIENTS WERE ASSIGNED TO THE NKP GROUP AND 113 TO THE NKF GROUP. THE TOTAL INITIAL SUCCESS RATE OF BILIARY CANNULATION (ISRBC) OF THE PRECUT TECHNIQUES (BOTH NKP AND NKF) FOR PATIENTS WITH DBC WAS 91.5%. THE ISRBC OF PATIENTS IN THE NKP GROUP WAS SIMILAR TO THAT OF THE NKF GROUP (90.7% VS 92.0%, P>.05). THE ISRBC OF THE PATIENTS IN THE SWOLLEN MDP SUBGROUP (96.1%) WAS HIGHER THAN THAT OF PATIENTS IN THE DISTORTED MDP SUBGROUP (81.8%, P=.030). THE TOTAL AND SPECIFIC COMPLICATIONS OF THE PATIENTS OF THE NKP GROUP WERE SIMILAR TO THOSE OF THE NKF GROUP (P>.05). THIS STUDY CONCLUDED THAT NKP AND NKF, AS SELECTED

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Unspecified Hepatic or Biliary Problem

  MAUDE report 15142136 ↗