DISPOSABLE PAPILLOTOMY KNIFE KD-211Q-0725Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170040337), received between Sep 25, 2020 and Nov 21, 2023 — classified as 1 death, 2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC INTERNALIZATION BY CUTTING VERSUS REMOVAL OF THE ENDOSCOPIC TRANSPAPILLARY NASO-GALLBLADDER DRAINAGE TUBE IN PREOPERATIVE MANAGEMENT OF ACUTE CHOLECYSTITIS: A RETROSPECTIVE MULTICENTER COHORT STUDY." ABSTRACT BACKGROUND: ENDOSCOPIC TRANSPAPILLARY NASO-GALLBLADDER DRAINAGE (ENGBD)HAS BEEN REPORTED TO BE AN EFFECTIVE TREATMENT OPTION FOR ACUTE CHOLECYSTITIS. AT OUR INSTITUTION, ENGBD WAS FIRST PLACED FOR EXTERNAL FISTULA MANAGEMENT, AND ENDOSCOPIC INTERNALIZATION BY CUTTING WAS PERFORMED, SHIFTING TO ENDOSCOPIC TRANSPAPILLARY GALLBLADDER STENTING (EGBS) AFTER IMPROVEMENT OF CHOLECYSTITIS. HOWEVER, THERE HAS BEEN NO COMPARATIVE STUDY TO DEFINE WHICH PREOPERATIVE MANAGEMENT IS BETTER: CONVERTING ENGBD TO EGBS OR REMOVING ENGBD. THE STUDY AIMED TO COMPARE THE INCIDENCE RATE OF THE LATE ADVERSE EVENTS (AES) RELATED TO BILIARY SYSTEM BETWEEN SHIFTING FROM ENGBD TO EGBS AND REMOVAL OF ENGBD. METHODS: WE RETROSPECTIVELY STUDIED 122 PATIENTS WHO UNDERWENT ENGBD FOR ACUTE CHOLECYSTITIS BETWEEN (B)(6) 2010 AND (B)(6) 2022. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: THE CUTTING GROUP (CONVERTING ENGBD TO EGBS) AND THE REMOVAL GROUP (R

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

  MAUDE report 18185296 ↗
• MalfunctionJun 9, 2023Break; Break

  A CUSTOMER REPORTED TO OLYMPUS, DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE KNIFE WIRE BROKE AFTER THE THIRD ENERGIZATION. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100925 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: PERMANENT ENDOSCOPIC GALLBLADDER STENTING VERSUS REMOVAL OF GALLBLADDER DRAINAGE,LONG-TERM OUTCOMES AFTER MANAGEMENT OF ACUTE CHOLECYSTITIS IN HIGH-RISK SURGICAL PATIENTS FOR CHOLECYSTECTOMY:MULTI-CENTER RETROSPECTIVE COHORT STUDY" BY A. MARUTA, T. IWASHITA, AND KEISUKE IWATA ET AL.     ENDOSCOPIC TRANSPAPILLARY GALLBLADDER DRAINAGE (EGBD) HAS BEEN REPORTED AS AN EFFECTIVE GALLBLADDER DRAINAGE TREATMENT OPTION FOR ACUTE CHOLECYSTITIS IN HIGH-RISK SURGICAL PATIENTS. HOWEVER, THE LONG-TERM OUTCOMES SUCH AS CHOLECYSTITIS' RECURRENCE RATE AFTER PLACEMENT OF EGB STENTING (EGBS) HAVE NOT BEEN WELL STUDIED YET. THE AUTHORS USED 3 OLYMPUS DEVICES AND DID NOT SPECIFY THE ADVERSE EVENTS IN RELATION TO THE DEVICES AND THEREFORE, THE ADVERSE EVENTS WILL BE REPORTED FOR ALL OLYMPUS DEVICES (B)(6): KD-V411M-0725. (B)(6): KD-211Q-0725. COMPLAINT 3 VISIGLIDE2. 1 - PANCREATITIS. 1 - CYSTIC DUCT INJURY, MANAGED CONSERVATIVELY. 3 - BILE PERITONITIS, MANAGED CONSERVATIVELY. LATE ADVERSE EVENTS (6 MONTHS AND 1 YEAR). 22 - CHOLECYSTITIS REOCCURRENCE. 11 -COMMON BILE DUCT STONES. 3 - COMMON BILE DUCT STONES AND REOCCURRENCE OF CHOLECYSTITIS. THIS IS REPORT 2 OF

  Patient problems: Pancreatitis; Peritonitis; Unspecified Hepatic or Biliary Problem

  MAUDE report 13604552 ↗
• DeathFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON FEBRUARY 1, 2021, OMSC RECEIVED THE LITERATURE " SMALL ENDOSCOPIC SPHINCTEROTOMY PLUS ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION FOR REMOVING CHOLEDOCHOLITHIASIS IN PATIENTS WITH PERIPAPILLARY DIVERTICULUM". THE PURPOSE OF THE LITERATURE WAS TO ASSESS THE SAFETY AND EFFECTIVENESS OF SMALL ENDOSCOPIC SPHINCTEROTOMY(SEST) PLUS ENDOSCOPIC PAPILLARY LARGE BALLOON DILATION (EPLBD)FOR REMOVING REFRACTORY CHOLEDOCHOLITHIASIS IN PATIENTS WITH PERIPAPILLARY DIVERTICULUM. THE SUBJECT PATIENTS WERE 137 PATIENTS WITH REFRACTORY CHOLEDOCHOLITHIASIS STONES(DIAMETER=15 MM)CONCOMITANT WITH PERIPAPILLARY DIVERTICULUM, TREATED AT THE FIRST AFFILIATED HOSPITAL OF WANNAN MEDICAL COLLEGE BETWEEN NOVEMBER 2012 AND OCTOBER 2015. 66 PATIENTS RECEIVED SEST+EPLBD (GROUP A) AND THE OTHER 71 (GROUP B), CONVENTIONAL ENDOSCOPIC SPHINCTEROTOMY (EST). IN THE LITERATURE, IT WAS REPORTED THAT THERE WAS ONE CASE OF BLEEDING, AND EVENTUALLY DEATH DUE TO PULMONARY EMBOLISM IN THE GROUP B. THE AUTHOR WROTE, ONE CASE IN THE CONVENTIONAL EST GROUP HAD POSTOPERATIVE BLEEDING AND EVENTUALLY DIED DUE TO PULMONARY EMBOLISM, POSTOPERATIVE BLEEDING WAS CONSIDERED TO BE RELATED TO THE LARGE MAGNITUDE OF PAPILLARY SPHINCTER

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Pulmonary Embolism

  MAUDE report 11284008 ↗
• MalfunctionNov 9, 2020Break; Break

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE SUBJECT DEVICE WAS USED. THE DISTAL END OF THE SUBJECT DEVICE BROKE AND FELL OFF. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS ALSO REPORTED THAT THE DISTAL END OF THE SUBJECT DEVICE DID NOT FALL INTO BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10808477 ↗
• MalfunctionSep 25, 2020Break; Break

  WE RECEIVED THE FOLLOWING REPORT. DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST), THE SUBJECT DEVICE WAS USED. THE CUTTING KNIFE OF THE DEVICE BROKE DURING THE OPERATION. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10584664 ↗