Isi has not received the instrument involved with this complaint, therefore the root cause of the customer reported failure cannot be determined.A follow up mdr will be submitted if the instrument is returned and/or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment broke off and fell inside the patient.Although, the fragment was retrieved and no patient harm was reported, it is unknown what caused the breakage to occur.
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It was reported that during a da vinci-assisted hysterectomy procedure, a piece of plastic from the long bipolar grasper instrument broke off and fell inside the patient.The fragment was retrieved during the same surgical procedure.There was no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) has made multiple follow up attempts to obtain additional information, however, no additional information has been received as of date of this report.
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