Isi received the pch instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint.The pch instrument was found to have the conductor wire insulation damaged near the distal idler pulley.Material appeared to be lifted off and the bare wire was exposed.The electrical continuity test passed.Additionally, the pch instrument was found to have thermal damage to the distal clevis, monopolar yaw pulley, and proximal clevis.Material appeared to have burned off from the charring that occurred near the conductor wire.Any potential fragments would likely be thermally induced, rather than mechanically induced.One side of the distal clevis ear was removed and the silicone potting did not appear to be compromised.The conductor wire was not damaged around the weld location.A review of the instrument log for the pch instrument (lot # n10190327-562) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2020 on system usg806.The alleged event occurred on the 10th use of the instrument.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.Based on the information provided at this time, this complaint is being reported due to the following conclusion: the permanent cautery hook instrument arced, smoked, or had conductor wire damage with no evidence or claim of user mishandling or misuse.Although there was no report of patient harm, if this event were to recur it could cause or contribute to an adverse event.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is not applicable because the product is not implantable.The information for initial reporter's name and address is not available.
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It was reported that during a da vinci-assisted abdominoperineal resection surgical procedure, there was smoke coming out from the tip of the permanent cautery hook (pch) instrument each time the surgeon used it during dissection.The instrument had 0 lives remaining following the procedure, indicating that the reported issue occurred on the pch instrument's last allotted usage.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on (b)(6) 2020 and obtained the following additional information: the pch instrument and cannula were inspected prior to use and there was no damage nor anything out of the ordinary.The customer did not use a pin gauge to inspect the cannula.The customer used a valleylab generator with cut and coag set to 30.The customer observed arcing.The pch instrument was in use for a couple hours before the surgeon noticed the smoke.A cadiere forceps instrument and fenestrated bipolar forceps instrument were also in use when the arcing event occurred.The pch instrument did not collide with any other instrument or tool and the pch instrument tips did not touch any stapler, clips, or sutures while energized.The pch instrument tips were in contact with tissue when the arcing event occurred.The pch instrument jaws had not been immersed in liquid or contaminated by carbonized tissue.The pch instrument was not removed at any time prior to the arcing event.There was no damage to the pch instrument noted after the arcing event.The surgeon did not know what caused the arcing event.There was no injury to the patient and the patient has not returned to the hospital due to experiencing any post-surgical complications as a result of the arcing event.No image or video is available for review.The procedure was delayed by about 30 minutes due to the issue.The patient was (b)(6) years old at the time of the procedure, date of birth (b)(6), and female.
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