Single Use Biliary Drainage Stent V PBD-1030-1005Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170346125), received between Feb 14, 2023 and Feb 14, 2023 — classified as 1 death, 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 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.

• DeathFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "POSTOPERATIVE OUTCOMES OF RESECTABLE PERIAMPULLARY CANCER ACCOMPANIED BY OBSTRUCTIVE JAUNDICE WITH AND WITHOUT PREOPERATIVE ENDOSCOPIC BILIARY DRAINAGE." THIS RETROSPECTIVE SINGLE CENTER COHORT STUDY AIMED TO EVALUATE POSTOPERATIVE OUTCOMES IN TERMS OF POSTOPERATIVE COMPLICATIONS, LENGTH OF HOSPITAL STAYS, AND MORTALITY IN PATIENTS WITH PERIAMPULLARY CANCERS WHO UNDERWENT CURATIVE SURGICAL RESECTION WITH OR WITHOUT PREOPERATIVE BILIARY DRAINAGE (PBD) IN 104 PATIENTS. THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS WAS 58.6% IN THE PBD GROUP WHILE 73.9% IN THE DIRECT SURGERY (DS) GROUP (RELATIVE RISK [RR] 1.26, 95% CONFIDENCE INTERVAL [CI] 0.92, 1.73, P=0.155) AND THE DIFFERENCE WAS NOT SIGNIFICANT EXCEPT IN BILE LEAKAGE (RR 8.83, 95% CI 1.26, 61.79, P = 0.021) AND INTRAOPERATIVE BLEEDING (RR 3.97, 95% CI 0.88, 17.85, P = 0.049) WHICH WERE HIGHER IN THE DS GROUP. THE ONE-YEAR SURVIVAL RATE WAS SLIGHTLY LESS IN THE DS GROUP. THE STUDY RESULTS CONFIRMED THAT PBD MAY BE NOT NECESSARY FOR ALL RESECTABLE PERIAMPULLARY CANCER PATIENTS, BUT THERE MIGHT BE A ROLE IN THOSE WITH SEVERELY JAUNDICE (>14.6 MG/ DL), AS IT HELPS LOWER RISK OF INTRAOPE

  Patient problems: Insufficient Information

  MAUDE report 16371438 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "POSTOPERATIVE OUTCOMES OF RESECTABLE PERIAMPULLARY CANCER ACCOMPANIED BY OBSTRUCTIVE JAUNDICE WITH AND WITHOUT PREOPERATIVE ENDOSCOPIC BILIARY DRAINAGE." THIS RETROSPECTIVE SINGLE CENTER COHORT STUDY AIMED TO EVALUATE POSTOPERATIVE OUTCOMES IN TERMS OF POSTOPERATIVE COMPLICATIONS, LENGTH OF HOSPITAL STAYS, AND MORTALITY IN PATIENTS WITH PERIAMPULLARY CANCERS WHO UNDERWENT CURATIVE SURGICAL RESECTION WITH OR WITHOUT PREOPERATIVE BILIARY DRAINAGE (PBD) IN 104 PATIENTS. THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS WAS 58.6% IN THE PBD GROUP WHILE 73.9% IN THE DIRECT SURGERY (DS) GROUP (RELATIVE RISK [RR] 1.26, 95% CONFIDENCE INTERVAL [CI] 0.92, 1.73, P=0.155) AND THE DIFFERENCE WAS NOT SIGNIFICANT EXCEPT IN BILE LEAKAGE (RR 8.83, 95% CI 1.26, 61.79, P = 0.021) AND INTRAOPERATIVE BLEEDING (RR 3.97, 95% CI 0.88, 17.85, P = 0.049) WHICH WERE HIGHER IN THE DS GROUP. THE ONE-YEAR SURVIVAL RATE WAS SLIGHTLY LESS IN THE DS GROUP. THE STUDY RESULTS CONFIRMED THAT PBD MAY BE NOT NECESSARY FOR ALL RESECTABLE PERIAMPULLARY CANCER PATIENTS, BUT THERE MIGHT BE A ROLE IN THOSE WITH SEVERELY JAUNDICE (>14.6 MG/ DL), AS IT HELPS LOWER RISK OF INTRAOPE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Hepatic or Biliary Problem; Unspecified Infection

  MAUDE report 16371430 ↗