Single Use Biliary Stent V PBD-203-0707Recalls & reported problems
Olympus Medical Systems Corp. · Single Use Biliary Stent V · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170186370), received between May 21, 2022 and May 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling 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
Device problems
- Device Markings/Labelling Problem1
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.
MalfunctionMay 21, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE CUSTOMER REPORTED THAT WHEN INSPECTING THE BILIARY STENT BEFORE USE DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE CONTENTS OF THE BOX WERE DIFFERENT FROM THE OUTER BOX. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14466142 ↗
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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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