Kopans G02586Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002025868), received between Mar 23, 2017 and Aug 13, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A (B)(6) MODIFIED BREAST LESION LOCALIZATION NEEDLE WAS USED DURING A BREAST LESION LOCALIZATION PROCEDURE. WHEN THE PHYSICIAN INSERTED THE NEEDLE INTO THE PATIENT¿S BREAST, THE NEEDLE BROKE AND A SECTION WAS LEFT BEHIND IN THE BREAST. THE PHYSICIAN WAS ABLE TO REMOVE THE PARTIAL NEEDLE WITH ANOTHER INSTRUMENT AFTER CT SCANNING. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7779250 ↗
• MalfunctionApr 23, 2018Break; Break

  IT WAS REPORTED DURING A BREAST LOCALIZATION, A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE SNAPPED WHEN THE SURGEON MANIPULATED IT AFTER IT WAS PLACED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450060 ↗
• InjuryNov 2, 2017Fracture; Fracture

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING PLACEMENT OF THE HOOK WIRE PORTION OF THE KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE, PART OF THE EXTERNAL WIRE REPORTEDLY SNAPPED OFF IN THE RADIOLOGIST'S HANDS AS THE DEVICE WAS BEING SECURED TO THE PATIENT'S CHEST WITH A DRESSING. TO SECURE THE DEVICE, IT IS REPORTEDLY COMMON PRACTICE TO BEND THE EXTERNAL WIRE A LITTLE. THE PATIENT UNDERWENT A SCHEDULED PROCEDURE ON THE SAME DAY, DURING WHICH THE PATIENT'S LUMP WAS RESECTED AND THE COMPLAINT PRODUCT WAS TO BE RETRIEVED; IT WAS THEN DISCOVERED DURING THIS PROCEDURE THAT THE A SECTION OF WIRE HAD ALSO FRACTURED JUST UNDER THE PATIENT'S SKIN AS WELL. THE OPERATOR REMOVED BOTH THE HOOK WIRE AND THE DISCOVERED WIRE FRAGMENT FROM THE PATIENT. ALL FRAGMENTS OF THE WIRE WERE ULTIMATELY RECOVERED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6996304 ↗
• InjuryMar 23, 2017Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT UNDERWENT A BREAST EXCISION ON (B)(6) 2016 WITH PLACEMENT OF A KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE. THE PATIENT PRESENTED TO THE CLINIC ON (B)(6) 2017 WITH A COMPLAINT THAT A SECTION OF THE WIRE CAME OUT OF HER BREAST. THE SURGICAL SITE WAS EXAMINED AND REPORTEDLY "EVERYTHING IS FINE AND NO INFECTION" WAS FOUND. THE PATIENT GAVE THE EXTERNALIZED SECTION OF THE NEEDLE TO THE PHYSICIAN. THE CIRCUMSTANCES AND HANDLING OF THE DEVICE FOR TWO MONTHS POST BREAST EXCISION ARE NOT KNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6427462 ↗