Biliary Drainage Tube PBD-421-1004Recalls & reported problems
Olympus Medical Systems Corp. · Biliary Drainage Tube · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170046919), received between Sep 6, 2024 and Sep 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (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.
Reports received per month
Most reported problems
Device problems
- Migration or Expulsion of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 6, 2024Migration or Expulsion of Device; Migration or Expulsion of Device
IT WAS REPORTED THAT THE PROCEDURE FOR PLACING THE STENT WAS A BILIARY STENT PLACEMENT AND THE DEVICE MIGRATED INTO THE BILE DUCT. THE ENDOSCOPIC IMAGES FROM THE INITIAL EXAMINATION CONFIRMED THE STENT WAS PLACED WITHOUT ANY PROBLEMS. IT WAS REPORTED THAT THE PATIENT IS STILL ALIVE (THERE HAVE BEEN NO REPORTS OF DEATH OR WORSENING OF THE PATIENT'S CONDITION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163497 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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