Intuitive surgical, inc.(isi) received the medium-large clip applier instrument associated with this complaint and completed its investigation.The failure analysis investigations confirmed the customer reported complaint of "tip broken." failure analysis found the primary failure of broken grip tips to be related to the customer reported complaint.The instrument was found to have a broken grip at the clip grooves.A piece approximately 0.068" x 0.086" was found to be broken off the grips.The broken piece was not returned.The root cause of the failure is typically attributed mishandling/misuse such as excess force applied to the instrument jaws.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.A review of the site's system logs for the reported procedure date was conducted by rpms analyst.Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint.However, the system log indicates the medium-large clip applier instrument associated with this event was last used on (b)(6) 2021 on system (b)(4).The instrument had 39 lives remaining.This complaint is a reportable event due to the following conclusion: failure analysis confirmed the instrument's grip was at the grip base.This instrument is designed with a grip pin on the distal end allowing articulation of the instrument assemblies they are holding together and is secured to the device by swaging.If the pin is not properly fused together, the pin could become dislodged and fall into the patient.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.
|