It was reported that, during a navio assisted ukr surgery, the anspach emax 2 plus hand piece - rohs was really hot and the cable is destroyed.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed beyond the reported problem.
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Section h10: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with wear and tear as a result of repeated use.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4).Section h6 (impact code) was corrected.
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