The device was not returned for analysis, which precluded a full investigation and analysis of the root cause.However, based on information received from the customer the event occurred as a result of the user removing the marker applicator separately from the probe.Tip shear has been identified as a potential risk whenever the applicator shaft is removed separately through the biopsy probe once it has been positioned in the probe aperture for marker deployment.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft once it is exposed to the probe aperture creates the possibility of the applicator catching on one of these edges and shearing.As a mitigation step to address this risk, we provide warnings and precaution language and instruction within the instructions for use: warning: failure to align the mammomark applicator as specified may result in improper deployment of the collagen plug and possible tip shear.Warning #10: remove the mammomark applicator and the mammotme biopsy probe together as a single unit from the site and obtain images to confirm marker placement.A dhr review of this device lot number was conducted.The performance specifications and the components demonstrated high process capability to the specification.There were no abnormalities or deficiencies found.It was noted during the investigation that the device used during this event was expired.The customer used the device approximately twenty-three months after the purchase date.This time period is beyond product expiration which is clearly marked on the packaging in the yyyy-mm format.Within the product ifu warnings and precautions section, the statement "do not use product beyond the expiration date" is visible.Although the use of the device beyond its expiry is not identified as a contributor to the event as described, device performance was evaluated for potential impact.No known performance issues associated with this event were noted within the fmea.The pathology results are still pending at the time of this report.No additional follow-up care information is available at this time.However, due to the potential for a subsequent procedure or other treatment intervention, we are submitting this medwatch report.Device discarded by the customer.
|