Intuitive surgical, inc.(isi) has not received the mega suturecut needle driver instrument for evaluation.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.No image or video clip for the reported event was submitted for review.A review of system and instrument log was performed.The instrument was last used on (b)(6) 2022 on system sl0215 for 0:12:30 sec.The mega suturecut needle driver has 0 uses remaining after last use.The instrument has max 15 uses.This complaint is being reported due to the following conclusion: it was alleged that the instrument broke inside the patient during a da vinci assisted procedure.The customer reported that it was unknown if any fragments fell inside the patient as a result of the breakage.There were no fragments identified or retrieved during the procedure.At this time it is unknown what caused the breakage to occur.
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It was reported that during a da vinci-assisted hysterectomy surgical procedure, a cable broke on the mega suturecut needle driver instrument inside the patient.The customer was unsure if any fragments had fallen into the patient.The customer ordered an x-ray for the patient.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon stated that no visible fragments were identified.There were no fragments retrieved from the patient.No additional procedure was required.The customer performed an axr (abdominal x-ray).The surgeon did not know what could have caused the cable break; the instrument was on its last use.The instrument was in use for approximately five minutes when the issue was identified.The surgeon was suturing when the instrument stopped working; no fragments were seen.The surgeon was not sure if the instrument was inspected prior to use.The instrument did not collide with other instruments or hard materials.The instrument was not removed prior to the breakage.Upon instrument removal, the wrist was straightened.To his knowledge, the staff did not notice any resistance upon removal of the instrument through the cannula or damage.There are no images or video recordings of the procedure available for isi review.
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