It was reported that before a navio tka procedure, when plugging in the anspach drill before registration, they received an e9 error.They unplugged the drill and saw that one of the prongs at the end of the anspach cord had receded.They opened a new drill and were able to register without causing delays.No other complications were reported.
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H3, h6: the navio drill, part number pfsr101209, s/n (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The connector has a crimp terminal that is pushed in.A functional evaluation was performed.The reported e9 error was not confirmed, and the device performed as intended.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.Although the reported e9 failure was not confirmed, no reasonable contributing factors could be identified based on the received complaint information and investigation results.The most likely cause for the connector is mechanical component failure.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.
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