Additional information provided in d.10., h.3., h.6., and h.10.Ten unopened probes were received with tip protectors, in trays along with other unused items, for the report of probe lengthened while cutting.A sampling of four samples were visually inspected for loose needles only and all four samples were found to be conforming with no loose needles observed.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The samples evaluated were found to be conforming, therefore the customer complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the probes evaluated were manufactured according to specification.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.The manufacturer internal reference number is: (b)(4).
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