As reported (b)(6) 2016, a patient of unknown age and gender presented for a microwave procedure of the liver.It was reported during the procedure, the applicator tip was bending.The tip remained fully attached to the applicator shaft while in the patient.The applicator was set aside and a new of the same device was used to successfully complete the procedure.It was reported the patient did not suffer harm or injury due to the event.It was reported the disposable device is available for return to the manufacturer for evaluation.
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The customers reported complaint of a broken fiber could not be confirmed because no sample was returned for evaluation.Without confirming the complaint, a root cause cannot be determined.The patient was unaffected due to this event.A review of the lot history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.At the vendor facility, during the manufacturing process, fibers are repeatedly bent and coiled and there is a final visual inspection performed with a hene laser to check the entire fiber length for defects prior to shipment.During the packaging step, the fibers are inspected for damage.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.The instructions for use, which is supplied to the end user with this catalog number contains the following statement "prior to and during use, avoid damaging the fiber by striking, stressing or excessive bending.Do not coil the fiber tighter than a radius of 60 mm".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).Device not available for return.
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Returned for evaluation was one pmta accu2i standard applicator.A visual examination of the device noted that the tip of the applicator was broken.Functional testing could not be performed due to the condition of the returned device.The customer's reported complaint description of the tip fracture 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.Based on the device history review this event does not appear to be due to a manufacturing defect.A possible contributing factor could have been operational context; i.E.Probe placement into hard tissue or lateral forces on the applicator tip during placement or removal.The ifu states; "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.(b)(4).
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