Cook G00810Recalls & reported problems
Cook Incorporated · Chiba Biopsy Needle · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002008106), received between Sep 17, 2021 and Sep 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2021Material Separation; Material Separation
THERE WERE NO ISSUES ADVANCING THE NEEDLE. IT WAS CONFIRMED THAT THE OUTER TROCAR WAS THE DEVICE COMPONENT THAT SEPARATED. IMAGING PROVIDED BY THE FACILITY SHOWS A DEVICE FRAGMENT REMAINING IN THE SOFT TISSUE OF THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 12488401 ↗
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.