During a dnc hysteroscopy, it was reported that the control unit for the hysteroscopic morcellator handpiece began smoking when plugged in together.It was reported that there was not a backup device available during the procedure.In order to remove the polyp, the surgeon proceeded through the working channel with a scope and a pair of graspers to complete the case.(b)(4).
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Subject device was received and evaluated.The reported complaint has been confirmed.The device was found to have a short circuit that caused the discovered damage to the control unit.The design of the truclear hand piece incorporates a field replaceable cable.The cable was removed and damage to the hand piece receptacle was revealed.Hand piece receptacle pins have been bent in a clock wise direction.This impairment has caused the control unit to short circuit.It seems that the operator has attempted to remove and replace the cable and in the process damaged the connector pins of the hand piece receptacle.This, in turn caused damage to the truclear control unit.The complaint investigation has determined user error.It is suggested that the user refer to the cable replacement instructions that can be found hysterscopic morcellation system ifu (instruction for use).Subject device will require a non-warranty repair.Per results of the investigation, the root cause has been determined to be bent pins due to user error.At this time, no further investigation will be implemented.(b)(4).
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