Intuitive surgical, inc.(isi) has not received the tip cover accessory for failure analysis.Therefore, the root cause of the customer reported failure mode cannot be determined.If additional information is received, a follow-up mdr will be submitted.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the tip cover accessory fell off inside the patient.The tip cover accessory was retrieved.However, at this time it is unknown what caused the tip cover accessory to fall off.
|
It was reported that during a da vinci-assisted hysterectomy procedure, the tip cover accessory detached from the monopolar curved scissors (mcs) instrument and fell inside the patient.The tip cover accessory was retrieved.The procedure was completed with no report of patient harm, adverse outcome or injury.
|