The mcs tip cover accessory will not be returned to isi for evaluation; therefore the root cause of the customer reported failure mode cannot be determined.A follow up mdr will be submitted if the instrument is returned or if additional information is received.This complaint is being reported due to the following conclusion: it was alleged that the mcs tip cover accessory fell inside the patient.The tip cover accessory was reported to have been retrieved during the same da vinci surgical procedure.Although, there was no report of patient harm, adverse outcome or injury, it is unknown what caused the tip cover accessory to fall inside the patient.
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It was reported that during a da vinci-assisted right nephrectomy surgical procedure, the tip cover accessory that was installed on a monopolar curved scissors (mcs) instrument fell inside the patient.The tip cover accessory was retrieved during the same procedure with an unspecified instrument.The procedure was completed and no adverse event was reported.On (b)(4) 2017 intuitive surgical inc., (isi) contacted the site's robotics coordinator and obtained the following additional information: the tip cover accessory that was installed on the monopolar curved scissors (mcs) instrument fell inside the patient right under the surgeon's vision.The surgeon immediately retrieved the tip cover accessory.It was also confirmed that the surgeon never took his eye off the tip cover accessory.It was also confirmed that there were no instrument collisions reported.The robotics coordinator also confirmed that the cannula and the instruments were inspected prior to use.The robotics coordinator confirmed that the procedure was completed robotically.The surgical task of cutting tissue was completed with another mcs instrument.The robotics coordinator confirmed that there was no patient harm, adverse outcome or injury.The robotics coordinator also confirmed that the tip cover accessory was contaminated and hence it was discarded.
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