It was reported that, when trying to leave the case after a navio-assisted pfa surgery, a "handpiece control motor failure" message was displayed.They tried to leave the case and shut the system down, but the error appeared a second time.The patient was not harmed.
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H3, h6: the navio handpiece, part number pfsr110137, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed.The reported problem was confirmed.Upon attempting to perform a handpiece test, the system outputted a handpiece connection error.Review of the patient case screenshots confirms the reported allegation of "handpiece exposure control motor failure." a review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.The most probable cause of the reported problem is electrical failure within the handpiece cable.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.Additional information: d10.
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