Cook G00895Recalls & 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 00827002008953), received between Jun 23, 2023 and Jun 23, 2023 — 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.
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.
MalfunctionJun 23, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17195130 ↗
Other DEVICE, PERCUTANEOUS, BIOPSY devices
- Cook G00012Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall2 reports
- Cook G03314Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G03978Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G01559Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G04338Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00013Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G00852Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
- Cook G05040Cook Incorporated · DEVICE, PERCUTANEOUS, BIOPSY1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.