It was reported that after a da vinci-assisted radical prostatectomy with lymphadenectomy surgical procedure, a burn was identified on the beige coating of the maryland bipolar forceps instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information.The instrument was inspected prior to use with no damage noted.No interoperative collisions occurred.The damage was identified after reprocessing the instrument.No image or procedure video are available for review.The customer stated no injury to the patient occurred.
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Intuitive surgical, inc.(isi) has not received the maryland bipolar forceps for evaluation.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if additional information is obtained.A review of the instrument log for the maryland bipolar forceps instrument (pn# 471172-17 lot# k10220203-0411) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for approximately 49 minutes.The alleged event occurred on the 10th use of the instrument with 4 uses remaining.No image or procedure video was provided for review.This complaint is being classified as a reportable event due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.At this time, it is unknown what caused the thermal damage to occur.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.
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