CANNULA PR-110Q-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170043765), received between Aug 8, 2023 and Feb 4, 2025 — classified as 3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARATIVE STUDY OF THERAPEUTIC OUTCOMES IN PATIENTS WHO DEVELOPED HEPATOLITHIASIS AFTER HEPATICOJEJUNOSTOMY: BALLOON-ASSISTED ENTEROSCOPIC APPROACH VERSUS PERCUTANEOUS TRANSHEPATIC APPROACH." BACKGROUND: THE TREATMENT OF HEPATOLITHIASIS IN PATIENTS WHO UNDERWENT HEPATICOJEJUNOSTOMY (HJS) IS CHALLENGING. IN THIS STUDY, WE AIMED TO CLARIFY THE THERAPEUTIC OUTCOMES OF DOUBLE BALLOON ENTEROSCOPY (DBE) AND PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) FOR HEPATOLITHIASIS AFTER HJS. METHODS: PATIENTS WHO UNDERWENT DBE OR PTBD FOR HEPATOLITHIASIS AFTER HJS AT HIROSHIMA UNIVERSITY HOSPITAL WERE ENROLLED, AND TREATMENT OUTCOMES AND RECURRENCE WERE COMPARED. RESULTS: FORTY-EIGHT OF THE 84 ELIGIBLE PATIENTS UNDERWENT DBE, WITH THE HJS SITE REACHED IN 42 PATIENTS (87.5%; DBE GROUP). FORTY-ONE PATIENTS UNDERWENT PTBD (PTBD GROUP). THERE WERE NO DIFFERENCES IN THE CLINICAL CHARACTERISTICS AND STONE-RELATED FACTORS, INCLUDING LOCALIZATION, MAXIMUM DIAMETER, AND QUANTITY, BETWEEN BOTH GROUPS. THE COMPLETE STONE REMOVAL RATES IN THE DBE AND PTBD GROUPS WERE 85.7% AND 90.2%, RESPECTIVELY. THE DBE GROUP HAD A SIGNIFICANTLY SHORTER MEDIAN LENGTH

  Patient problems: Cholangitis

  MAUDE report 21303669 ↗
• InjuryOct 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED " EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY AND ENDOSCOPIC PANCREATIC STENTING WITHOUT PANCREATIC SPHINCTEROTOMY FOR THE TREATMENT OF PANCREATOLITHIASIS: A CASE SERIES." LITERATURE SUMMARY: THIS STUDY DISCUSSED ENDOSCOPIC THERAPY AND EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL) AS RECOMMENDATIONS FOR THE FIRST CHOICE IN TREATING PANCREATOLITHIASIS. THE INPATIENT TREATMENT PLAN WAS PERFORMED EVERY 3 MONTHS WITH A SET NUMBER OF SESSIONS OF ESWL WITH ENDOSCOPIC PANCREATIC STENTING (EPS) IMPLANTED OR REPLACED. A TOTAL OF 8 PATIENTS WERE INVOLVED IN THIS CASE SERIES WITH A MEDIAN AGE OF 69 YEARS. THE MEDIAN TIME FROM INITIAL TREATMENT TO TARGET STONE DISAPPEARANCE WAS 208.5 DAYS (RANGE, 4¿452). SYMPTOMS IMPROVED AFTER THE INITIAL INPATIENT TREATMENT IN ALL PATIENTS. THE MEDIAN FOLLOW-UP TIME AFTER STONE DISAPPEARANCE WAS 950 DAYS, WITH TWO CASES OF STONE RECURRENCE. MILD PANCREATITIS OCCURRED TWICE IN ERCP AND ONCE IN ESWL. THREE CASES OF STENT DISLOCATION WERE OBSERVED; DISLOCATION THAT DID NOT MEET THE SEVERITY GRADE OCCURRED TWICE OF THE THREE CASES. HENCE, COMBINING ESWL WITH EPS WITHOUT EPST CAN TREAT PANCREATOLITHIASIS SAFELY. TYPE OF A

  Patient problems: Pancreatitis

  MAUDE report 17851278 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR BELIEVES THAT THIS IS A COMPLICATION THAT OCCURS DURING THE PROCEDURE AS A WHOLE, NOT BECAUSE OF THE DEVICE.

  Patient problems: Cholangitis; Pancreatitis

  MAUDE report 17482372 ↗