It was reported that during a da vinci-assisted umbilical hernia surgical procedure, a mega suture needle driver jaw broke inside the patient.The surgeon did not see the instrument break, but it was recognized while the surgeon attempted to use the instrument again.The caller stated that they did fluoroscopy and located the jaw inside the patient but the surgeon elected not to retrieve the fragment as it was very small, and it might cause injury trying to retrieve it.The procedure was completed.Isi made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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Intuitive surgical, inc.(isi) has not received the mega suture needle driver instrument for evaluation although it has been requested for return.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints related to this product.An instrument log review would not show any information related to instrument breakage.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the a mega suture needle driver jaw broke inside the patient.The fragment was not retrieved.At this time it is unknown what caused the breakage to occur.Blank mdr field information: follow-up was attempted, but the patient information for blank fields either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.It is unknown if the initial reporter submitted a report to the fda.Insufficient product information was provided in order to obtain the date of manufacture.
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Additional information can be found in the following fields: a2, a3, a4, a5, a6, d4, d9, e4, g3, g6, h2, h3, h6, and h10.D11- the mega suture needle driver instrument has been returned and evaluated by the failure analysis team (b)(6) 2022.Failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of broken grip tips to be related to the customer reported complaint.The instrument was found to have a broken grip at the grip base.A piece approximately 0.121" x 0.354" was found to be broken off.The broken piece was not returned.The root cause of broken instrument grips tip is typically attributed to mishandling/misuse, such as excess force applied to the instrument jaws.A review of the instrument log for the mega suture needle driver instrument (471309-15/n11210818 0061) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2021.Intuitive surgical, inc.(isi) received mw5105495 stating: "part of the robotic needle driver broke off during surgery; attempt to localize with fluoroscopy was unsuccessful.A robotic repair for an umbilical hernia repair was being performed.While closing the incision within the abdomen.It was noted that a portion of the tip of the robotic needle driver broke off.The surgeons did not see the instrument break, but it was recognized when using the instrument again.The tip of the jaw had broken off.The surgeons used x-rays to locate it.Although they could see it on x-ray, they were not able to locate it within the loops of intestine because it was so small.It should be noted that there were adhesions from prior surgery and treatment that prohibited the surgeons from exploring all areas where the tip could have moved to.The surgeon decided to abort the operation because the risk of injuring the intestines was greater than the risk of the tip of the instrument causing harm to the patient by injuring the intestines or other vital structure.After the patient was recovered from anesthesia.The surgeon discussed the event with the patient.Fda safety report id # (b)(4)." intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the nurse clarified that the surgeon was able to complete the procedure using the da vinci system, however they elected not to convert to open nor try to retrieve the fragment based on a risk assessment.The customer reported that the risk of injury to try to retrieve the fragment was higher than the risk of injury to just leave it inside the patient.The fragment currently remains inside the patient.As of (b)(6) 2021, the nurse has not been made aware of any patient injury nor post-operative complication as a result of the issue.The nurse confirmed that the issue occurred upon the instruments first use.There was no damage noted prior to use and there was no instrument collision.
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