CANNULA PR-104Q-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170043604), received between May 18, 2023 and Feb 6, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD FOR PATIENTS WITH POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS, INCLUDING PANCREATIC CARCINOMA IN SITU." BACKGROUND/AIMS: THIS STUDY AIMED TO CLARIFY THE EFFICACY AND SAFETY OF PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD (PLC-CB) FOR POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS (PDACS). METHODS: THIS STUDY INCLUDED 41 PATIENTS WITH SUSPECTED PDACS WHO UNDERWENT PLC-CB MAINLY BECAUSE THEY WERE UNFIT FOR UNDERGOING ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION. A 6-FR DOUBLE LUMEN CATHETER WAS MAINLY USED TO PERFORM PLC-CB. FINAL DIAGNOSES WERE OBTAINED FROM THE FINDINGS OF RESECTED SPECIMENS OR CLINICAL OUTCOMES DURING SURVEILLANCE AFTER PLC-CB. RESULTS: HISTOCYTOLOGICAL EVALUATIONS USING PLC-CB WERE PERFORMED IN 87.8% (36/41) OF THE PATIENTS. FOR 31 OF THE 36 PATIENTS, FINAL DIAGNOSES (INVASIVE PDAC, 12; PANCREATIC CARCINOMA IN SITU, 5; BENIGNANCY, 14) WERE MADE, AND THE REMAINING FIVE PATIENTS WERE EXCLUDED DUE TO LACK OF SURVEILLANCE PERIODS AFTER PLC-CB. FOR 31 PATIENTS, THE SENSITIVITY, SPECIFICITY, AND ACCURACY OF PLC-CB FOR DETECTING

  Patient problems: Pancreatitis

  MAUDE report 18650055 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD FOR PATIENTS WITH POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS, INCLUDING PANCREATIC CARCINOMA IN SITU.". BACKGROUND/AIMS: THIS STUDY AIMED TO CLARIFY THE EFFICACY AND SAFETY OF PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD (PLC-CB) FOR POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS (PDACS). METHODS: THIS STUDY INCLUDED 41 PATIENTS WITH SUSPECTED PDACS WHO UNDERWENT PLC-CB MAINLY BECAUSE THEY WERE UNFIT FOR UNDERGOING ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION. A 6-FR DOUBLE LUMEN CATHETER WAS MAINLY USED TO PERFORM PLC-CB. FINAL DIAGNOSES WERE OBTAINED FROM THE FINDINGS OF RESECTED SPECIMENS OR CLINICAL OUTCOMES DURING SURVEILLANCE AFTER PLC-CB. RESULTS: HISTOCYTOLOGICAL EVALUATIONS USING PLC-CB WERE PERFORMED IN 87.8% (36/41) OF THE PATIENTS. FOR 31 OF THE 36 PATIENTS, FINAL DIAGNOSES (INVASIVE PDAC, 12; PANCREATIC CARCINOMA IN SITU, 5; BENIGNANCY, 14) WERE MADE, AND THE REMAINING FIVE PATIENTS WERE EXCLUDED DUE TO LACK OF SURVEILLANCE PERIODS AFTER PLC-CB. FOR 31 PATIENTS, THE SENSITIVITY, SPECIFICITY, AND ACCURACY OF PLC-CB FOR DETECTIN

  Patient problems: Pancreatitis

  MAUDE report 18649982 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD FOR PATIENTS WITH POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS, INCLUDING PANCREATIC CARCINOMA IN SITU." BACKGROUND/AIMS: THIS STUDY AIMED TO CLARIFY THE EFFICACY AND SAFETY OF PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD (PLC-CB) FOR POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS (PDACS). METHODS: THIS STUDY INCLUDED 41 PATIENTS WITH SUSPECTED PDACS WHO UNDERWENT PLC-CB MAINLY BECAUSE THEY WERE UNFIT FOR UNDERGOING ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION. A 6-FR DOUBLE LUMEN CATHETER WAS MAINLY USED TO PERFORM PLC-CB. FINAL DIAGNOSES WERE OBTAINED FROM THE FINDINGS OF RESECTED SPECIMENS OR CLINICAL OUTCOMES DURING SURVEILLANCE AFTER PLC-CB. RESULTS: HISTOCYTOLOGICAL EVALUATIONS USING PLC-CB WERE PERFORMED IN 87.8% (36/41) OF THE PATIENTS. FOR 31 OF THE 36 PATIENTS, FINAL DIAGNOSES (INVASIVE PDAC, 12; PANCREATIC CARCINOMA IN SITU, 5; BENIGNANCY, 14) WERE MADE, AND THE REMAINING FIVE PATIENTS WERE EXCLUDED DUE TO LACK OF SURVEILLANCE PERIODS AFTER PLC-CB. FOR 31 PATIENTS, THE SENSITIVITY, SPECIFICITY, AND ACCURACY OF PLC-CB FOR DETECTING

  Patient problems: Pancreatitis

  MAUDE report 18649889 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD FOR PATIENTS WITH POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS, INCLUDING PANCREATIC CARCINOMA IN SITU." BACKGROUND/AIMS: THIS STUDY AIMED TO CLARIFY THE EFFICACY AND SAFETY OF PANCREATIC DUCT LAVAGE CYTOLOGY COMBINED WITH A CELL-BLOCK METHOD (PLC-CB) FOR POSSIBLE PANCREATIC DUCTAL ADENOCARCINOMAS (PDACS). METHODS: THIS STUDY INCLUDED 41 PATIENTS WITH SUSPECTED PDACS WHO UNDERWENT PLC-CB MAINLY BECAUSE THEY WERE UNFIT FOR UNDERGOING ENDOSCOPIC ULTRASONOGRAPHY-GUIDED FINE NEEDLE ASPIRATION. A 6-FR DOUBLE LUMEN CATHETER WAS MAINLY USED TO PERFORM PLC-CB. FINAL DIAGNOSES WERE OBTAINED FROM THE FINDINGS OF RESECTED SPECIMENS OR CLINICAL OUTCOMES DURING SURVEILLANCE AFTER PLC-CB. RESULTS: HISTOCYTOLOGICAL EVALUATIONS USING PLC-CB WERE PERFORMED IN 87.8% (36/41) OF THE PATIENTS. FOR 31 OF THE 36 PATIENTS, FINAL DIAGNOSES (INVASIVE PDAC, 12; PANCREATIC CARCINOMA IN SITU, 5; BENIGNANCY, 14) WERE MADE, AND THE REMAINING FIVE PATIENTS WERE EXCLUDED DUE TO LACK OF SURVEILLANCE PERIODS AFTER PLC-CB. FOR 31 PATIENTS, THE SENSITIVITY, SPECIFICITY, AND ACCURACY OF PLC-CB FOR DETECTING

  Patient problems: Pancreatitis

  MAUDE report 18649814 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "REQUEST FOR BILIARY DRAINAGE FOR IGG4-SC COULD BE WAIVED BEFORE STEROID ADMINISTRATION?". BACKGROUND: IN IGG4-RELATED SCLEROSING CHOLANGITIS (IGG4-SC), THE NECESSITY OF BILIARY DRAINAGE (BD) IS UNCLEAR. IN THIS STUDY, WE AIMED TO RETROSPECTIVELY INVESTIGATE THE IMPROVEMENT OF LIVER DAMAGE AND JAUNDICE IN CASES OF IGG4-SC WITH AND WITHOUT BD, BEFORE STARTING STEROIDS. METHODS: A TOTAL OF 52 PATIENTS WITH IGG4-SC WERE INVESTIGATED IN THE STUDY. THE STUDY ENDPOINTS WERE THE NORMALIZATION RATE OF ALKALINE PHOSPHATASE (ALP)/TOTAL BILIRUBIN (T-BIL) AFTER 8 WEEKS OF STEROIDS, WITH AND WITHOUT BD. RESULTS: PROPENSITY SCORE MATCHING WAS PERFORMED BASED ON ALP AND T-BIL, AND 28 PATIENTS WERE INCLUDED. THERE WERE 14 PATIENTS EACH IN THE BD AND NON-BD GROUPS. BEFORE INITIATION OF STEROIDS, THE MEAN ALP IN THE BD GROUP AND THE NON-BD GROUP WAS 378/461 (P = .541); THE MEAN T-BIL WAS 2.5/1.8 (P = .401). EIGHT WEEKS AFTER INITIATION OF STEROIDS, ALP IMPROVEMENT RATE IN THE BD GROUP/ NON-BD GROUP WAS 69.2%/61.5% (P = 1.000), AND T-BIL IMPROVEMENT RATE WAS 100%/100% (P = NS). CONCLUSIONS: STEROIDS FOR IGG4-SC COULD PROVE EFFECTIVE IN IMPROVING LIVER

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 16952821 ↗