Kopans G02554Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002025547), received between Mar 27, 2018 and Jan 27, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2022Break; Break

  A NEEDLE LOCALIZATION WAS COMPLETED FOR A PATIENT USING A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE. THE PROCEDURE WAS REPORTED TO HAVE BEEN SUCCESSFUL AND THE PATIENT WAS TAPED AND SENT FOR SURGERY. APPROXIMATELY AN HOUR LATER, THE NURSE CAME DOWN TO THE MAMMOGRAPHY DEPARTMENT WITH "PART OF THE NEEDLE." SHE STATED THAT IT BROKE OFF AT THE LEVEL WHERE THE WIRE GOES INTO THE BREAST. THE SCRUB NURSE IN THE CASE STATED THE PHYSICIAN HAD USED A CAUTERY DEVICE AND MAY HAVE TOUCHED THE WIRE AND THE "WIRE SHOT UP AWAY FROM THE BREAST." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367834 ↗
• InjuryAug 27, 2020Material Separation; Material Separation

  IT WAS REPORTED A FEMALE PATIENT REQUIRED PLACEMENT OF A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE FOR A HOOK WIRE INSERTION FOLLOWED BY WIDE LOCAL EXCISION OF A RIGHT BREAST LESION. AFTER INSERTION INTO THE BREAST LESION, THE RADIOGRAPHER NOTED THAT THE HOOK WIRE WAS BROKEN INTO TWO PIECES, ONE INSIDE THE BREAST AND THE OTHER OUTSIDE THE BREAST. THE PHYSICIAN REMOVED BOTH PORTIONS OF THE WIRE AS WELL AS "MORE" BREAST TISSUE AT THE SURGICAL SITE TO ENSURE THE LESION AND WIRE WERE TAKEN OUT "DUE TO LACK OF LOCALIZATION." THIS RESULTED IN A POORER COSMETIC OUTCOME OF THE BREAST. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 10463618 ↗
• MalfunctionSep 10, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS INSERTED INTO THE PATIENT VIA STEREOTACTIC GUIDANCE PRIOR TO A PROCEDURE. POST WIRE MAMMOGRAMS WERE THEN PERFORMED WITHOUT COMPLICATION. THE WIRE WAS SECURED TO THE PATIENT AFTER THE MAMMOGRAM. AS THE PATIENT WALKED TO ANOTHER ROOM, THE WIRE BROKE IN TWO, LEAVING ONE END STILL ANCHORED IN THE PATIENT'S BREAST. THE RADIOLOGIST SECURED THE SMALL EXTERNAL PIECE OF THE WIRE WITH TAPE UPON NOTICING THE WIRE HAD BROKEN. A SECOND WIRE WAS REQUIRED WHICH WAS UNRELATED TO THE FIRST WIRE BREAKING, AND UPON INSERTION, THE RADIOLOGIST NOTICED THAT THE FIRST WIRE HAD BROKEN AT THE PROXIMAL END NEAR THE HUB. A SECOND SERIES OF POST WIRE MAMMOGRAM SHOWED BOTH THE INTACT AND BROKEN WIRES. BOTH WIRES WERE SUCCESSFULLY REMOVED DURING THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7859796 ↗
• InjuryMar 27, 2018Material Separation; Material Separation

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A HOOK WIRE LOCALIZATION OF MALIGNANT LESION IN LEFT BREAST IN WHICH THE KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS EMPLOYED, THE HOOK PORTION OF THE PRODUCT BROKE OFF AND WAS LEFT IN THE PATIENT'S PECTORALIS MUSCLE. THE PHYSICIAN HAD INITIALLY INSERTED A HOOK WIRE, BUT THE POST PROCEDURE MAMMOGRAM DID NOT SHOW THE LOCATION OF THE HOOK INSIDE THE LESION. A SECOND HOOK WIRE WAS THEN INSERTED WHICH DID PROPERLY MARK THE LESION, AND THE SURGEON WAS INFORMED ABOUT THE USE OF TWO WIRES. THE SECOND HOOK WIRE WAS REMOVED WITH NO ISSUED ALONG WITH THE LESION DURING THE SURGERY, BUT IT WAS DURING THE REMOVAL OF THE FIRST HOOK WIRE THAT THE HOOK BECAME LODGED IN THE PATIENT'S MUSCLE. THE REST OF THE WIRE WAS RETRIEVED AS EXPECTED; ONLY THE 1 CM PORTION OF THE HOOK WIRE WAS RETAINED. IMAGING LATER CONFIRMED THE LOCATION OF THE RETAINED PIECE OF THE DEVICE. THE COMPLAINT DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7373753 ↗