Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigation identified a broken curved blade measuring approximately 0.47" x 0.10" in size.The broken piece was not returned with the instrument.Cracked or broken blades are triggered by any inadvertent contact with staples, clips, or other instruments while the device is activated.In addition, scratches on the blade tip may also lead to premature blade failure.Blade damage may be detected by the generator with a solid tone or an error.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 procedure video was provided for review.A review of the instrument log for the harmonic ace instrument lot# m90200324 / sequence 0030 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2021 on system (b)(4).The instrument is single use.This complaint is considered a reportable malfunction due to the following conclusion: failure analysis investigations found missing piece from the distal end of the instrument.The missing piece could fall inside the patient during the surgical procedure.While there was no reported 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 inside the patient may require surgical intervention.
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It was reported that during a da vinci-assisted distal pancreatectomy procedure, the user observed physical damage on the harmonic ace instrument.The user completed the procedure using the backup instrument with no further issue reported.No fragment fell inside the patient.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instruments that were used intraoperatively were successfully removed and no further information can be provided.
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