CANNULA PR-113Q-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170043840), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JULY 5, 2021, OMSC RECEIVED THE DOCUMENT "SINGLE-STAGE RETROGRADE ENDOSCOPIC COMMON BILE DUCT STONE REMOVAL MIGHT BE SUFFICIENT IN MODERATE ACUTE CHOLANGITIS WITH A STONE SIZE =12 MM: A RETROSPECTIVE COHORT STUDY WITH PROPENSITY SCORE MATCHING". THE PURPOSE OF THE LITERATURE WAS TO ACCESS OF SINGLE-STAGE ENDOSCOPIC TREATMENT FOR COMMON BILE DUCT (CBD) STONE REMOVAL IN PATIENTS WITH MODERATE CHOLANGITIS TO DETERMINE THE RATES OF SUCCESSFUL STONE EXTRACTION AND COMPLICATIONS. AFTER THE RANDOMIZED PROPENSITY SCORE MATCHING, THERE WERE 90 AND 134 PATIENTS IN THE MODERATE AND NO/MILD CHOLANGITIS GROUPS, RESPECTIVELY. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WAS PERFORMED USING A SIDE VIEW ENDOSCOPE (OLYMPUS; JF-260, TJF-240) AND A CATHETER (OLYMPUS; PR-113Q). A BALLOON-TIPPED CATHETER AND A GUIDEWIRE WERE ALSO USED AND MANUFACTURED BY NON-OLYMPUS. THE PRIMARY OUTCOMES WERE SUCCESS RATE OF COMPLETE STONE REMOVAL AND RATES OF MAJOR COMPLICATIONS INCLUDING POST-ERCP PANCREATITIS (PEP), PERFORATION, BLEEDING, PNEUMONIA, AND MORTALITY WITHIN 30 DAYS OF THE PROCEDURE. CASES NOT REQUIRING TRANSFUSION WERE DEFINED AS MILD BLEEDING, THOSE REQUIRING UP TO FOUR UNITS OF BLOOD WERE

  Patient problems: Abscess; Adult Respiratory Distress Syndrome; Pancreatitis; Sepsis

  MAUDE report 12250107 ↗