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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.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation (b)(6) informed cook on 13jan2022 of an incident involving a kopans modified breast lesion localization needle (rpn: dkbl-21-9.0-a) from lot 8022138 which occurred on 11jan2022.A needle localization with breast tissue removal in surgery was being completed.The access site was the breast; the target site was within the breast tissue.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." the product broke at the start of the incision process by the surgeon.The surgeon performing the operation was reported to be a new surgeon and may have hit the wire with the electrosurgical device and snapped it.No excessive force was required during the procedure.No angle correction of the inserted needle was required to reach the desired target.There may have been additional resistance when inserting the needle due to prior breast biopsy and clip placement.No part of the device remained in the patient.The patient required no additional procedures because of this incident.No additional adverse effects were reported.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control procedures were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhrs for the reported complaint device lot 8022138 and the related hookwire subassembly lots sa7793806 and sa7793807 revealed no relevant non-conformances.A database search for complaints on these lots found no additional complaints reported from the field.Based on the available information, cook has concluded that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, [t_dkbl_rev2] ¿kopans breast lesion localization needle,¿ provides the following information to the user related to the reported failure mode: precautions: ¿following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement.¿ instructions for use: ¿4.Remove the needle.5.Bend the hookwire protruding from the breast and tape flat to the skin.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ from the information provided upon review of the customer testimony, dmr, dhr, and ifu, cook concluded that the device was manufactured to specification.Cook could confirm that there were no nonconforming devices in house or out in the field.Based on the information provided, no returned device, and the results of the investigation, cook has concluded that unintended user error contributed to this incident.From the customer¿s statement it is possible that the physician performing the second stage of the operation when the wire was broken may have accidentally cut the wire while using the electrosurgical device, but this cannot be confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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