The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the marker delivery system separately from the probe aperture once the spring is exposed creates the possibility of it catching on one of these edges.As a mitigation step to address this risk, we provide instructions within the instructions for use: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement.
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Devicor medical products, inc.Received a report from user facility, stating, tip shear occurred during stereo biopsy.Doctor left in the breast because they are waiting to see if patient will go to surgery once pathology report comes back.Doctor pulled marker out of the probe instead of removing the probe/marker as one unit.This has been documented in our system as record #(b)(4).
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