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Cook G03954Recalls & reported problems

Cook Incorporated · Chiba Biopsy Needle · 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 00827002039544), received between Oct 5, 2017 and Oct 5, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 5, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    THE CUSTOMER REPORTED THAT, DURING AN INSPECTION OF THE CHIBA BIOPSY NEEDLE WHICH OCCURRED PRIOR TO USE, A HAIR WAS VISIBLE THROUGH THE PRODUCT PACKAGING. THE PACKAGE WAS REPORTEDLY NOT USED ON A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS OCCURRED. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

    Patient problems: No Patient Involvement

    MAUDE report 6918157 ↗

Other DEVICE, PERCUTANEOUS, BIOPSY devices

All DEVICE, PERCUTANEOUS, BIOPSY devices →

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