Isi received the mcs tip cover accessory involved with this complaint and completed the device evaluation.Failure analysis was unable to confirm the customer reported failure.The mcs tip cover accessory was placed on an in-house instrument and was tested on the system.The tip cover did not fall off.The issue could not be replicated.However, the mcs tip cover accessory was found to have a tear at the distal end.If additional information is received, a follow-up mdr will be submitted.The complaint is being reported due to the following conclusion: it was reported that approximately 16 months after undergoing a da vinci-assisted surgical procedure, the patient underwent an exploratory laparoscopic procedure where an mcs tip cover accessory was found and retrieved.The msc tip cover accessory had been retained in the patient for 16 months.
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It was reported that a "retained object found in patient almost one year after original procedure." on (b)(6) 2018, intuitive surgical, inc.(isi) obtained the following additional information from the site's robotic¿s coordinator regarding the reported event and sequence of events: the robotic¿s coordinator stated that on (b)(6) 2016, the patient had undergone a da vinci-assisted surgical procedure at their site to remove an ovarian mass.He confirmed that there were no intra-operative complications reported at that time.Approximately three months after the initial da vinci procedure, on a unspecified date, the patient had a laparoscopic cholecystectomy at their site with no issues reported.On a unspecified date, the patient then went in with lower right pelvic pain radiating to the appendix area.Hence, on (b)(6) 2018, the patient underwent an exploratory laparoscopic procedure.During this procedure, the surgeon found a foreign body near the appendix.The robotic¿s coordinator was called in to identify the retained foreign body and identified it as the monopolar curved scissors (mcs) tip cover accessory with the da vinci name on it.The robotic¿s coordinator was not sure if the appendix was removed, however, he did state that the surgeon who did the original da vinci procedure in (b)(6) 2016 was called in and the right ovary was removed secondary to an ovarian cyst.The robotic¿s coordinator confirmed that the surgeon retrieved the fragment with no reported intra-operative complications.The patient was informed about the issue, was discharged and recovering well.
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