Kopans G02587Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002025875), received between Oct 5, 2017 and Aug 8, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BETWEEN THE TIME A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS PLACED AND THE SCHEDULED PROCEDURE, THE MARKER MOVED. DUE TO THE LESION NOT CLEARLY IDENTIFIED, RESECTION WAS "IRRADICAL" AND THE SCHEDULED INTRAOPERATIVE RADIATION THERAPY (IORT) LED TO A RE-OPERATION. TRANSLATION OF FURTHER INFORMATION INDICATED: "SMALL TUMOR MASS RECOGNIZABLE BY A SMALL CALCIFICATION MARK, PATIENT HAD A LARGE COMMUTING MOM AND A LOT OF FAT AND A SMALL TUMOR, INGREDIENTS FOR DISLOCATION. THE WIRE IS PLACED WITH THE TIP THROUGH THE MASS, BUT THE BARB STILL HANGS IN THE GREASY TISSUE: M.I. THEN MORE LIKELY DISLOCATION IN THIS SINGLE BARB. WE ALMOST ALWAYS PLACE UNDER ULTRASOUND GUIDE, WHERE THE TIP OF THE NEEDLE IS PLACED JUST 1-5 MM THROUGH THE MASS AND THEN UNDER ECHO VIEW THE WIRE IS HELD IN PLACE WHILE THE NEEDLE IS RETRACTED. WHEN MASKING THE WIRE, AFTER MAMMOGRAPHICALLY DOCUMENTING CORRECT POSITION CC AND LM, THE THREAD IS ROLLED UP EXTERNALLY LOOSELY AND TAPED OFF WITH FIXOMUL, IN PATIENTS WITH SKIN THAT IS SUITABLE FOR THIS, NOT QUICK WOUNDS OR RASHES IN PLASTERS WITH TRANSPARENT PLASTIC ( 'SECOND SKIN', PRODUCT NAME ESCAPED ME). LOCALIZATIONS TAKE PLACE AT THE END OF T

  Patient problems: No Code Available

  MAUDE report 7764652 ↗
• InjuryJun 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS NOT IN THE CORRECT PLACE FOR THE SURGEON. THE PATIENT WAS TAKEN FROM THE OPERATING ROOM TO RADIOLOGY WHERE THE RADIOLOGIST PLACED A SECOND MARKER. AS REPORTED, THIS INCIDENT CAUSED A DELAY IN THE PROCEDURE, HOWEVER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7582398 ↗
• InjuryJun 8, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED WHILE USING A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE, THE DEVICE MIGRATED FROM THE INTENDED BREAST TUMOR LOCATION. THE RADIOLOGIST REMOVED AND REPOSITIONED THE DEVICE USING AN ULTRASOUND TO ESTABLISH CORRECT PLACEMENT. AS REPORTED, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7582384 ↗
• InjuryDec 12, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE WIRE INCLUDED IN THE KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE SET HAD DISLODGED FROM THE PATIENT. THE DEVICE HAD BEEN PLACED PRIOR TO A SCHEDULED LUMPECTOMY, AND THE PRODUCT ISSUE WAS NOTICED ONCE THE PATIENT REACHED THE OPERATING ROOM. AT THIS POINT, THE PATIENT WAS RESCHEDULED FOR ANOTHER PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN.

  Patient problems: No Code Available

  MAUDE report 7107559 ↗
• MalfunctionOct 5, 2017Fracture; Fracture

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE OPERATOR OF THE KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS "RESENTING THE LUMP AND RETRIEVING THE KOPANS MARKER NEEDLE" [SIC] AND IT ALLEGEDLY REMOVED IN THREE PIECES. THE PROCEDURE WAS A BREAST LUMP RESECTION. THE CUSTOMER CONFIRMED THAT THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE PRODUCT ISSUE, AND ALL PIECES OF THE DEVICE WERE RECOVERED FROM THE PATIENT. THE CIRCUMSTANCES SURROUNDING THE USAGE AND HANDLING OF THE DEVICE WERE NOT REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6917004 ↗