Intuitive surgical, inc.(isi) received the harmonic ace instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated and confirmed the customer reported complaint.The instrument was found to have a broken blade.The blade broke at roughly 0.24¿ from the base.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.The root cause of the ¿broken instrument blades¿ is typically attributed to instrument mishandling and misuse.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 was provided.A review of the instrument log for the harmonic ace instrument lot# m90200720 / sequence 0036 associated with this event has been performed.Per logs, the instrument was last used on the reported event date of (b)(6) 2021 on system sk4112.The instrument has 0 remaining usable life, no subsequent use recorded.This complaint is considered a reportable malfunction due to the following conclusion: failure analysis investigations found a 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, and the customer had reported that no fragment fell inside 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.Follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.The product is not implantable.
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