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Cook G00003Recalls & reported problems

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002000032), received between May 7, 2018 and Jan 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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

  • Bent1
  • Delivered as Unsterile Product1

Patient problems

  • No Patient Involvement2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 21, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Patient problems: No Patient Involvement

    MAUDE report 8264214 ↗
  • MalfunctionMay 7, 2018Bent; Bent

    IT WAS REPORTED THE ONE-PART PERCUTANEOUS ENTRY NEEDLE WAS NOTED TO BE BENT AS IT WAS REMOVED FROM IT'S PACKAGING. THE DEVICE WAS NOT USED DURING A PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Patient problems: No Patient Involvement

    MAUDE report 7492090 ↗

Other Trocar devices

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