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 inside the patient.The tip cover accessory was retrieved.At this time, 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 cystectomy procedure, as the monopolar curved scissor (mcs) instrument was being removed, the mcs tip cover accessory was noted to have fallen inside the patient.The tip cover accessory was retrieved and the procedure was completed with no report of patient harm, adverse outcome or injury.Intuitive surgical, inc.(isi) followed up obtained the following additional information from the clinical sales representative (csr): the mcs tip cover accessory appeared to be installed correctly.No part of the orange surface was visible after the mcs tip cover accessory was installed.The mcs tip cover accessory was not installed beyond the orange surface or over the shaft.
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