It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.A review of the device history records was performed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.(b)(4).
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As reported (b)(6) 2015, patient of unknown age and gender presented for an microwave procedure of the liver.During the procedure, after withdrawal, the treating physician noted the tip of the applicator probe was been.The tip of the applicator had not detached from the shaft of the probe and no wires were exposed.The device was set aside and a new of the same device was used to successfully complete the procedure.It was reported the patient suffered no harm or injury due to the event.The reported disposable device is not available for return to the manufacturer for evaluation as it was disposed of by the user.
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Returned for evaluation was one pmta accu2i intermediate applicator.Visual examination noted that tip of the applicator was bent.The tip did not fully detach.The reported complaint description of the tip of the applicator bending is confirmed.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Although the exact root cause of the event is unable to be determined, it does not appear to be the result of a manufacturing failure.A possible contributing factor could have been handling damage; i.E.Lateral forces on the applicator tip.The instructions for use, which is supplied to with catalog number, contains a statement "always advance the applicator into the target tissue using axial forces only.Avoid placing lateral forces on the applicator tip during placement or removal" and lateral forces on the applicator tip should be avoided both during insertion and removal.Failure to do so could result in damage to the microwave array, failure of the applicator and injury to the patient." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).
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