(b)(4).The dhr for the instrument in question, was reviewed and found completely without any irregularities.This instrument was manufactured at (b)(6) facility as part of a 50pc.Lot in january of 2016.The returned instrument was evaluated and found that the knob and tube assembly move freely back and forth when the handle is squeezed indicating the snap ring which holds the knob & tube assembly to the handle has been popped out of its groove thus validating the complaint.Parts were 100% visually inspected and tested at the (b)(6 )facility before instruments were sent to customer.No irregularities were found and or reported at the time of inspection and assembly of the product, as this is a standardized process for all instruments manufactured at this facility.Instrument was disassembled and it was found that the end of the drive rod that connects to the jaws and the jaws both were damaged.We are unable to determine how this instrument has been stored, handled and cleaned by the end users facility.At this time it is undetermined as to what other remarks: caused the shaft and knob assembly to become loose from the handle but mishandling at the customers site is suspected.No corrective action required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.Manufacturers must also report to the fda when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur." this incident is not reportable at this time with the information provided.
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