An rma has been issued to the customer requesting to have the instrument returned; however, isi has not yet 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 device logs for the maryland bipolar forceps (part# 471172-16 | lot/serial# (b)(4)) associated with this event has been performed.Per this review of the logs, the maryland bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4).There were 9 uses remaining after this last usage.No photo or video was provided by the site for review.This complaint is considered 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 the missing patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.
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It was reported that during a da vinci-assisted liver resection surgical procedure, the maryland bipolar forceps cable was noted to be broken.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: it was confirmed the conductor wire insulation was melted.Thermal damage was also observed.The customer stated that there was no loss of cautery due to the reported issue.
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Intuitive surgical, inc.(isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation replicated and confirmed the customer reported complaint.Fa found the primary failure of damaged conductor wire insulation to be related to the customer reported complaint.For clarification, the maryland bipolar forceps instrument was found to have damage to the conductor wire¿s insulation at the distal end.The conductor wire was exposed as a result.The maryland bipolar forceps passed the electrical continuity test.A piece of insulation measuring approximately 0.03" x 0.09" was missing.There are also signs of thermal damage found.The root cause of this failure is attributed to a component failure.Additional observation not reported by site that is related to the primary failure: the instrument was found to have thermal damage on the bipolar yaw pulley.The root cause of this failure is attributed to mishandling/misuse.
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