It was reported that during an ultrasound guided breast biopsy through normal scattered density tissue, as the device was being removed, the needle of the device allegedly kept getting longer and did not completely come out of the coaxial.It was further reported that the cutting needle with the strips that covers the trough was allegedly found to detached from the biopsy unit.Reportedly, the white portion of the biopsy device and the end of the cutting needle were held in order to prevent it from completely detaching.There was no reported patient injury.
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H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4: (expiry date: 08/2026).H11: section a: through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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