It was reported that during a da vinci-assisted surgical procedure, the small grasping retractor instrument had a torn cable.There was no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on 17-mar-2022 and obtained the following additional information: the site could not provide additional information about the reported complaint as the issue occurred a long time ago.The reporter was unable to provide the event date and it is unknown at this time.
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Isi has not received the small grasping retractor instrument 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 site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported due to the following conclusion: it is unknown if a fragment fell 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 as unintended fragment(s) falling into the patient may require surgical intervention.
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Intuitive surgical, inc.(isi) received the small grasping retractor instrument involved with this complaint and completed the device evaluation.Failure analysis investigation confirmed the reported complaint.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The root cause of a broken pitch cable is a component failure.Pitch cable breakage occurs when tensile load exceeds the ultimate strength of the material.The pitch cable construction is designed to optimize load and fatigue (cycling) characteristics.Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip lengths, grip torque, and manufacturing tolerances are a few variables which can influence pitch cable failure.A review of the instrument log for the instrument (pn 470318-10/lot # n10190407-0100) associated with this event was performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(6) during a gastric bypass (roux-en-y) procedure.The instrument had four uses remaining after last use.
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