Single Use Biliary Drainage Stent V PBD-1030-1007Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170463310), received between Jun 19, 2024 and Jun 19, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration1
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.
MalfunctionJun 19, 2024Migration; Migration
OLYMPUS RECEIVED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF BILIARY STENTS IN MALIGNANT BILIARY STRICTURES." THIS RETROSPECTIVE STUDY WAS TO COMPARE THE EFFECTIVENESS OF SELF-EXPANDABLE METAL STENTS (SEMSS) AND PLASTIC STENTS (PSS) IN THE ENDOSCOPIC DRAINAGE OF MALIGNANT STRICTURES OF THE BILIARY TREE AND ITS SEQUELS FOR THE FUTURE OPTIMIZATION OF THIS TREATMENT METHOD. A TOTAL OF 618 PATIENTS WERE INCLUDED (456 IN THE PS GROUP AND 162 PATIENTS IN SEMS GROUP). IN THE PS GROUP, STRAIGHT STENTS EXHIBITED A LONGER MEDIAN PATENCY TIME THAN DPT STENTS (52 [21¿106] DAYS VS 34.5 [14¿73] DAYS; P = 0.001). A DECREASED MEDIAN STENT PATENCY TIME WAS OBSERVED IN THE PATIENTS WITH HIGH VS LOW OBSTRUCTION LEVEL (49 [20¿109] DAYS VS 66 [28¿136] DAYS; P = 0.003). MEDIAN (IQR) BILIRUBIN DROP WAS 37% (14%¿58%) IN THE SEMS GROUP AND 32% (9%¿53%) IN THE PS GROUP (P = 0.01). MOREOVER, THE PATIENTS IN THE SEMS GROUP SHOWED A CRP LEVEL DECREASE BY 10.5%, WHEREAS IN THE PS GROUP THE CRP LEVEL ROSE BY 17% (P = 0.02). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ACUTE PANCREATITIS (36 CASES). LIVER ABSCESS (25 CASES). BLEEDING (24 CASES). PERFORATION (8 CASES). CHOLECYSTITIS (5 CASES). OTHER (21 CASES).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566156 ↗
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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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