Strange G09108Recalls & reported problems
Cook Incorporated · Cook Strange Bile Duct Stone Exploration Set · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002091085), received between May 9, 2016 and May 9, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 5, 2026Open, Classified
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1784-2026 · Root cause: Incorrect or no expiration date · FDA record ↗
Most reported problems
Device problems
- Material Separation1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2016Material Separation; Material Separation
DURING A COMMON BILE DUCT EXPIRATION PROCEDURE, THE FIRST GALLSTONE THAT THE SURGEON RETRIEVED CAME EASILY. THE SURGEON THEN RE-ADVANCED THE BASKET THROUGH THE CATHETER WITH THE GRASPERS AND HE THINKS HE MAY HAVE KINKED THE WIRE WITH HIS GRASPERS. WHEN HE CAPTURED THE SECOND STONE WITH THE BASKET, HE FELT SOME RESISTANCE AND PULLED TO RETRIEVE THE STONE WHEN THE BASKET BROKE. AN INCISION WAS MADE THROUGH THE COMMON DUCT AND THE BASKET WAS REMOVED.
Patient problems: No Code Available
MAUDE report 5641412 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.