PANCREATIC STENT PBD-234-0806Recalls & reported problems
Olympus Medical Systems Corp. · 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 04953170152160), received between Feb 10, 2022 and Feb 10, 2022 — classified as 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Perforation1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: EARLY ENDOSCOPIC TREATMENT OF SYMPTOMATIC PANCREATIC NECROTIC COLLECTIONS BY BY M.JAGIELSKI, J. PIATKOWSKI AND M. JACKOWSKI. ABSTRACT: ENDOSCOPIC ULTRA-SOUND (EUS)-GUIDED TRANSMURAL ENDOSCOPIC DRAINAGE IS COMMONLY USED IN THE TREATMENT OF WALLED OFF PANCREATIC NECROSIS (WOPN) IN THE LATE PHASE OF ACUTE NECROTIC PANCREATITIS (ANP). THE ROLE OF ENDOSCOPIC INTERVENTION REMAINS UNCLEAR IN THE EARLY PHASE OF ANP. THIS STUDY AIMED TO PROSPECTIVELY EVALUATE EARLY ENDOSCOPIC TREATMENT OF ANCS COMPARED WITH ENDOSCOPIC DRAINAGE OF WOPN. OVERALL, 71 PATIENTS WITH ANP WHO UNDERWENT TRANSMURAL ENDOSCOPIC DRAINAGE FOR NECROTIC COLLECTIONS WERE INCLUDED. ENDOSCOPIC INTERVENTION WAS PERFORMED WITHIN THE FIRST FOUR WEEKS OF ANP IN 25 (35.21%) PATIENTS WITH ANC (GROUP 1) AND IN 46 (64.79%) PATIENTS AFTER FOUR WEEKS SINCE THE ONSET OF ANP WITH WOPN (GROUP 2). THE OVERALL MEAN AGE OF PATIENTS WAS 49.9 (22¿79) YEARS AND 59 OF THEM WERE MALES. THE MEAN TIME OF ACTIVE DRAINAGE AND DURATION OF TOTAL ENDOSCOPIC TREATMENT WAS 26.8 AND 16.9 DAYS (P= 0.0001) AND 270.8 AND 164.2 DAYS (P= 0.0001) IN GROUPS 1 AND 2, RESPECTIVELY. THE AVERAGE TOTAL NUMBER OF ENDO
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Thrombosis/Thrombus
MAUDE report 13505472 ↗
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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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