Device history record review: device history record review show no non-conformances with this manufacture lot.Fatigue testing of needles from this manufacture lot shows with 95% confidence that 99.9% of the lot would pass a minimum of 24 cycles.The instructions for use included with the product caution against the use of direct force and instruct the user to use the product under direct visualization.Date product received: product was not returned.Device identification: 3910-900-091.Visual inspection: where product was not returned a visual inspection was not performed.Functional inspection: where product was not returned a functional inspection was not performed.This is a known failure mode addressed in the risk management file for this product, and does not exceed expected occurrence rates.Occurrence rates are monitored for trends.Service history review: there has been no service on this device.Root cause(s): where the product was not returned an exact root cause could not be determined.Possible causes could be user related such as the needle contacting something hard like bone.Manufacturer error: with limited information the device history record was reviewed and there is nothing in the record that would attribute this to an error in manufacturing.
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