Single Use Biliary Drainage Stent V PBD-1033-0707Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170347320), received between May 25, 2022 and Sep 26, 2023 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2023Migration; Migration

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "REAL-LIFE PATENCY OF PLASTIC BILIARY STENTS IN THE PANDEMIC ERA: IS STENT REMOVAL AFTER 6 MONTHS SAFE AND EFFECTIVE?" THIS RETROSPECTIVE STUDY ANALYZE THE OUTCOMES OF PATIENTS WHO HAD DELAYED PLASTIC BILIARY STENT REMOVAL FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE PANDEMIC ERA. A TOTAL OF 120 PATIENTS WERE INCLUDED IN THE STUDY. THE MEAN TIME TO STENT REMOVAL WAS 4.9 ± 3.1 MONTHS (RANGE 2-19): 3.5 ± 1.3 MONTHS (RANGE 2-6) FOR CASES WITH EARLY REMOVAL AND 8.6 ± 3.1 MONTHS (RANGE 7-19) FOR DELAYED REMOVAL. STENT REMOVAL WAS SUCCESSFULLY PERFORMED IN ALL CASES. CASES WITH EARLY STENT REMOVAL PRESENTED MORE FREQUENTLY BENIGN BILIARY STRICTURES AS THE INDICATION FOR PLASTIC BILIARY STENT INSERTION (25.9 VS 7.7%; P = 0.02). THE DELAYED AND EARLY ADVERSE EVENTS WERE STATISTICALLY SIGNIFICANT, SPECIFICALLY STENT MIGRATION (20.5 VS 11.1%, P = 0.17), STENT DYSFUNCTION (17.9 VS 13.6%, P = 0.53), OBSTRUCTIVE JAUNDICE (2.6 VS 0.0%, P = 0.33), ACUTE CHOLANGITIS (10.3 VS 13.6%, P = 0.77), ACUTE PANCREATITIS (0.0 VS 1.2%, P = 1.0), HOSPITALIZATION (17.9 VS 14.8%, P = 0.66), OR BILIARY PATHOLOGY-RELATED MORTALITY (2.6 VS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17817520 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "REAL-LIFE PATENCY OF PLASTIC BILIARY STENTS IN THE PANDEMIC ERA: IS STENT REMOVAL AFTER 6 MONTHS SAFE AND EFFECTIVE?" THIS RETROSPECTIVE STUDY ANALYZE THE OUTCOMES OF PATIENTS WHO HAD DELAYED PLASTIC BILIARY STENT REMOVAL FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE PANDEMIC ERA. A TOTAL OF 120 PATIENTS WERE INCLUDED IN THE STUDY. THE MEAN TIME TO STENT REMOVAL WAS 4.9 ± 3.1 MONTHS (RANGE 2-19): 3.5 ± 1.3 MONTHS (RANGE 2-6) FOR CASES WITH EARLY REMOVAL AND 8.6 ± 3.1 MONTHS (RANGE 7-19) FOR DELAYED REMOVAL. STENT REMOVAL WAS SUCCESSFULLY PERFORMED IN ALL CASES. CASES WITH EARLY STENT REMOVAL PRESENTED MORE FREQUENTLY BENIGN BILIARY STRICTURES AS THE INDICATION FOR PLASTIC BILIARY STENT INSERTION (25.9 VS 7.7%; P = 0.02). THE DELAYED AND EARLY ADVERSE EVENTS WERE STATISTICALLY SIGNIFICANT, SPECIFICALLY STENT MIGRATION (20.5 VS 11.1%, P = 0.17), STENT DYSFUNCTION (17.9 VS 13.6%, P = 0.53), OBSTRUCTIVE JAUNDICE (2.6 VS 0.0%, P = 0.33), ACUTE CHOLANGITIS (10.3 VS 13.6%, P = 0.77), ACUTE PANCREATITIS (0.0 VS 1.2%, P = 1.0), HOSPITALIZATION (17.9 VS 14.8%, P = 0.66), OR BILIARY PATHOLOGY-RELATED MORTALITY (2.6 VS

  Patient problems: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Jaundice; Pancreatitis

  MAUDE report 17817457 ↗
• DeathSep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "REAL-LIFE PATENCY OF PLASTIC BILIARY STENTS IN THE PANDEMIC ERA: IS STENT REMOVAL AFTER 6 MONTHS SAFE AND EFFECTIVE?" THIS RETROSPECTIVE STUDY ANALYZE THE OUTCOMES OF PATIENTS WHO HAD DELAYED PLASTIC BILIARY STENT REMOVAL FOLLOWING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE PANDEMIC ERA. A TOTAL OF 120 PATIENTS WERE INCLUDED IN THE STUDY. THE MEAN TIME TO STENT REMOVAL WAS 4.9 ± 3.1 MONTHS (RANGE 2-19): 3.5 ± 1.3 MONTHS (RANGE 2-6) FOR CASES WITH EARLY REMOVAL AND 8.6 ± 3.1 MONTHS (RANGE 7-19) FOR DELAYED REMOVAL. STENT REMOVAL WAS SUCCESSFULLY PERFORMED IN ALL CASES. CASES WITH EARLY STENT REMOVAL PRESENTED MORE FREQUENTLY BENIGN BILIARY STRICTURES AS THE INDICATION FOR PLASTIC BILIARY STENT INSERTION (25.9 VS 7.7%; P = 0.02). THE DELAYED AND EARLY ADVERSE EVENTS WERE STATISTICALLY SIGNIFICANT, SPECIFICALLY STENT MIGRATION (20.5 VS 11.1%, P = 0.17), STENT DYSFUNCTION (17.9 VS 13.6%, P = 0.53), OBSTRUCTIVE JAUNDICE (2.6 VS 0.0%, P = 0.33), ACUTE CHOLANGITIS (10.3 VS 13.6%, P = 0.77), ACUTE PANCREATITIS (0.0 VS 1.2%, P = 1.0), HOSPITALIZATION (17.9 VS 14.8%, P = 0.66), OR BILIARY PATHOLOGY-RELATED MORTALITY (2.6 VS

  Patient problems: Cholangitis

  MAUDE report 17816625 ↗
• InjuryMay 25, 2022Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED DURING AN ERCP TO REMOVE A STENT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN PUSHING THE GRASPER DOWN THE SCOPE. THE PHYSICIAN PUSHED HARDER AND A PIECE OF BLUE PLASTIC CAME OUT OF THE END OF THE SCOPE. THE SCOPE WAS REMOVED AND AN ALTERNATIVE SCOPE WAS USED TO COMPLETE THE PATIENT'S PROCEDURE AS PLANNED. AN X-RAY WAS TAKING FOR THIS PATIENT AND THEY ARE UNABLE TO CONFIRM IF THE END OF THE PIGTAIL STENT (ALSO BLUE) WAS MISSING IN THE PATIENT. THE BLUE PLASTIC FRAGMENT RELEASED FROM THE FIRST SCOPE WAS RETRIEVED. IT IS UNKNOWN HOW IT WAS RETRIEVED. THE FACILITY REVIEWED THE USE HISTORY OF THE SCOPE AND DETERMINED IT WAS LAST USED TO IMPLANT A PIGTAIL STENT FOR A DIFFERENT PATIENT. THIS EVENT INCLUDES 2 REPORTS: (B)(6): TJF-260V, SCOPE. (B)(6): PBD-1033-0707, STENT. THIS IS REPORT 2 OF 2 FOR (B)(6): PBD-1033-0707, STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14497437 ↗