Cook G08297Recalls & reported problems
Cook Incorporated · Cystic Duct Introducer Set · Class 1
- 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 00827002082977), received between Apr 3, 2026 and Apr 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping1
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.
MalfunctionApr 3, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT HAIR-LIKE FOREIGN MATTER WAS IDENTIFIED WITHIN THE SEALED PACKAGING OF AN APPEL-BERCI CYSTIC DUCT INTRODUCER SET. IT WAS THEN DECIDED THAT THE DEVICE WOULD NOT BE USED. NO HARM HAS CURRENTLY BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781891 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.