Single Use Nasal Biliary Drainage Tube V PBD-V803W-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170309335), received between Oct 2, 2023 and Oct 2, 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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 AD

  Patient problems: Pancreatitis

  MAUDE report 17851301 ↗
• 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 17851255 ↗