The fenestrated bipolar forceps instrument has not been returned to isi for failure analysis investigations; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the unit is returned (post engineering evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the grasper broke off and fell inside the patient.The broken instrument piece was retrieved from the patient and there was no harm to the patient.However, it is unknown what caused the instrument breakage to occur.
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It was reported during a da vinci-assisted hysterectomy procedure, one of the graspers on the fenestrated bipolar forceps instrument broke at the base and fell inside the patient.The fragment was retrieved during the same procedure.There was no report of patient harm, adverse outcome or injury.
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