Single Use Cannula V PR-V220QRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170183614), received between Jan 6, 2023 and Jan 9, 2023 — classified as 2 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
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Hypoxia2
- Pancreatitis2
- Perforation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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-CENTER R
Patient problems: Hypoxia; Pancreatitis; Perforation
MAUDE report 16126459 ↗InjuryJan 6, 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-CENTER R
Patient problems: Hypoxia; Pancreatitis; Perforation
MAUDE report 16117455 ↗
Other Endoscopic retrograde cholangiopancreatography (ERCP) cannula devices
- Tandem XL M00535700Boston Scientific Corporation · Endoscopic retrograde cholangiopancreatography (ERCP) cannula11 reports
- Contour ERCP Cannula M00530860Boston Scientific Corporation · Endoscopic retrograde cholangiopancreatography (ERCP) cannula6 reports
- CANNULA PR-104Q-1Olympus Medical Systems Corp. · Endoscopic retrograde cholangiopancreatography (ERCP) cannula5 reports
- DISPOSABLE BENDING CANNULA PR-233QOlympus Medical Systems Corp. · Endoscopic retrograde cholangiopancreatography (ERCP) cannula5 reports
- BioShield 00711133US Endoscopy · Endoscopic retrograde cholangiopancreatography (ERCP) cannula4 reports
- Contour ERCP Cannula M00530870Boston Scientific Corporation · Endoscopic retrograde cholangiopancreatography (ERCP) cannula3 reports
- CANNULA PR-110Q-1Olympus Medical Systems Corp. · Endoscopic retrograde cholangiopancreatography (ERCP) cannula3 reports
- BioShield 00711124US Endoscopy · Endoscopic retrograde cholangiopancreatography (ERCP) cannula3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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