The serial number for the device has been provided.A review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation is currently underway.The information provided by bard represents all of 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 bard.
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It was reported that during a stereotactic breast biopsy, the device was connected to the mammography unit and the vacuum allegedly activated.The driver and probe were allegedly making a rattling noise, where the driver and probe gears connect with one another.The hcp proceeded with the procedure and reportedly was able to complete it successfully.The patient formed a hematoma and pressure with a cool bag was applied.
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After further review of this file, it was identified that the initial mdr date of awareness reported incorrectly and the appropriate date for the initial mdr date of awareness is 11/25/2015.Manufacturing review: a manufacturing review was conducted and the reported lot met all release criteria.Visual inspection: the sample was returned for evaluation.The driver was received with no visual discrepancies to the exterior of the device.However, upon further examination of the internal components, the driver was found to be contaminated with an unknown fluid.The front pcb switch was not working and the flexi circuit pcb was found to be corroded.Functional/performance evaluation: the driver failed to calibrate test probes due to the contamination and damaged internal components.A motor power and voltage test were unable to be performed due to the condition of the returned device.The damaged components were replaced and the driver passed all functional tests.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the driver was returned with no external visual discrepancies.An electrical test was performed, and the returned device failed.The device was able to power on, however the driver was unable to calibrate, to fully test the device.The internal components were examined and an unidentifiable residue was found in the interior of the driver.It is likely that the residue found in the driver, led to the reported issue.A definitive root cause for the unidentifiable residue within the driver could not be determined based upon available information.However, once the driver was serviced and cleaned, it was able to meet all functional requirements.Labeling review: current instructions for use: warnings: care must be taken when positioning the device trocar tip near the chest wall or skin margin.Complications: complications that may be associated with the use of the encor® biopsy device and driver are the same as those associated with the use of other biopsy devices.These may include injury to the skin, blood vessels, muscles, organs, bleeding, hematoma and infection.Directions for use: for handheld use: the ¿vac¿ (vacuum) button may be utilized to evacuate fluid or blood.Using the enabled sample rinse feature: depress the ¿vac¿ button/footswitch and press the ¿rinse sample¿ button on the control unit to rinse and evacuate the fluid from the tissue collection chamber.The information provided by bard represents all of 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 bard.
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