Kopans G03795Recalls & reported problems
Cook Incorporated · Kopans Breast Lesion Localization Needle · Class 1 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00827002037953), received between Jul 17, 2018 and Jul 17, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.
MalfunctionJul 17, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED DURING A BREAST LOCALIZATION PROCEDURE, A HAIR LIKE "FIBRE" WAS FOUND IN AN UNOPENED KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE POUCH. ANOTHER DEVICE WAS USED IN THE PROCEDURE. AS REPORTED, THE DEVICE DID NOT MAKE PATIENT CONTACT; THEREFORE, THIS DEVICE ISSUE DID NOT CAUSE AN ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Patient Involvement
MAUDE report 7693314 ↗
Other NEEDLE, TUMOR LOCALIZATION devices
- Kopans G02587Cook Incorporated · NEEDLE, TUMOR LOCALIZATION5 reports
- Kopans G02586Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 reports
- Kopans G02554Cook Incorporated · NEEDLE, TUMOR LOCALIZATION4 reports
- Tuflex 271641SOMATEX Medical Technologies GmbH · Needle, Tumor Localization2 reports
- Tuloc 271661SOMATEX Medical Technologies GmbH · Needle, Tumor Localization2 reports
- Kopans G02850Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
- Kopans G03507Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
- Kopans G02900Cook Incorporated · NEEDLE, TUMOR LOCALIZATION1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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