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Cook G00280Recalls & reported problems

Cook Incorporated · Percutaneous Entry Thinwall Needle One-Part · Class 2

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 00827002002807), received between Feb 7, 2023 and Feb 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

Most reported problems

Device problems

  • Contamination /Decontamination Problem1

Patient problems

  • Insufficient Information1
  • 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.

  • MalfunctionFeb 7, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    ADDITIONAL INFORMATION WAS RECEIVED 01MAR2023. A PHOTO PROVIDED BY THE CUSTOMER SHOWS A SMALL INSECT ON THE OUTSIDE OF THE NEEDLE COVER. THE DEVICE DID NOT GET NEAR THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

    MAUDE report 16312336 ↗

Other Trocar devices

All Trocar devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.