Johlin G25716Recalls & reported problems
Cook Ireland Ltd · Johlin, Pancreatic Wedge Stent and Introducer · Class 2 · Implant
Data updated Oct 16, 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 10827002257167), received between Mar 11, 2024 and Mar 11, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Advance” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Advance1
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.
InjuryMar 11, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem
AS PER SOURCE DOCUMENT: "IMPOSSIBLE TO GET THE PLASTIC STENT OUT OF THE DUOSCOPE. 3RD TIME. PLICATURE DU KT PORTEUR. OBLIGATION TO RETRIEVE ALL THE DEVICE AND TO INPUT 2 METAL STENTS." PATIENT OUTCOME: ADDITIONAL PROCEDURE AS PER CC FORM: "NEED TO PUT TWO METAL STENT INSTEAD." PATIENT/EVENT INFO - NOTES: 1. PLEASE INDICATE WHERE THE DEVICE WAS STORED PRIOR TO USE. IN OPERATING ROOM. 2. WHAT IS THE REORDER NUMBER, OUTER DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? NA. 3. WERE PREVIOUS PROCEDURES I.E. SPHINCTEROTOMY ETC. CARRIED OUT PRIOR TO PLACING THE DEVICE OVER THE PARTICULAR WIRE GUIDE? IF YES PLEASE INDICATE THE PROCEDURE PERFORMED. NA. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? NA. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? NA. 6. DID THE PATIENT INVOLVED EXHIBIT ALTERED ANATOMY OR TORTUOUS ANATOMY? NA. 7. IF NOT WITH THE DEVICE IN QUESTION, HOW WAS THE PROCEDURE FINISHED? FOR COMPLAINTS OCCURRING DURING USE (ONCE IN CONTACT WITH ENDOSCOPE) ALSO ASK: 1. HAD A SPHINCTEROTOMY BEEN PERFORMED PRIOR TO THIS OCCURRENCE? YES. 2. WHAT IS THE ENDOSCOPE MANUFACTURER, THE MODEL NUMBER AND WO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18874108 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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