Geenen G22107Recalls & reported problems
Cook Ireland Ltd · Geenen Pancreatic Stent · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002221079), received between Oct 5, 2017 and Nov 27, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 reports).
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
- Break2
- Use of Device Problem1
Patient problems
- Foreign Body In Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2018Break; Use of Device Problem; Break; Use of Device Problem
THIS FILE IS BEING REPORTED BASED ON THE FDA MDR MALFUNCTION PRECEDENCE "STENT FRACTURE". THE GPSO-5-3 COULDN'T GET IN THE PANCRATIC DUCT BECAUSE THE GPSO-5-3 DISTAL FLAP WAS BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8105123 ↗InjuryOct 5, 2017Break; Break
THIS FOLLOW UP MDR IS BEING SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS. STENT BROKEN. "AS PER COMPLAINT FORM: IN (B)(6) 2017, THE STENT WAS IMPLANTED BY THE SAME HOSPITAL AND PHYSICIAN. ON THE (B)(6) THE STENT SHOULD BE REMOVED. STENT WAS IN AN OPTIMAL POSITION, BUT COMPLETELY DISCOLOURED DARK. WHEN REMOVING, THE PART OF THE STENT WAS IN THE DUODENUM, FELL APART INTO THE SMALLEST PIECES. REST PIECE WITHOUT HARM WAS IN THE PANCREATIC DUCT.
Patient problems: Foreign Body In Patient
MAUDE report 6917313 ↗
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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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