Intuitive surgical, inc.(isi) has requested that the maryland bipolar forceps instrument be returned for evaluation, but it has not yet been returned.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 or this event.No image or video was provided for review.A review of the instrument log for the maryland bipolar forceps instrument (part# 471172-16/lot# n10210419 0118) associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2021 using system sk3569.The instrument had 7 remaining usable lives with no subsequent use recorded.This complaint is being reported based on the following conclusion: it was alleged that the instrument had conductor wire damage with no evidence or claim of user mishandling or misuse.The damaged conductor wire has potential for electrical discharge at a location other than intended.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 the patient information in sections was either unknown, unavailable, not provided, or not applicable.The expiration date in section is not applicable.Field is blank because the product is not implantable.Information for the blank fields in section is not available.Fields are not applicable.
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It was reported that after a da vinci-assisted liver resection surgical procedure, the maryland bipolar forceps instrument was found to have a broken insulation.The issue was identified under the microscope in the sterile ward.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(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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