Intuitive surgical, inc.(isi) received the endoscope involved with this complaint and completed the device evaluation.Failure analysis (fa) replicated/confirmed the customer reported complaint.The endoscope had a missing gear and bearing.The endoscope had a damaged endoscope adapter (aea) and an rfid tag issue.The root cause of this failure is attributed to manufacturing.A review of the endoscope logs associated with this event has been performed.Per logs, the endoscope (470056-05/sf2038099) was last used on (b)(6) 2022 on system sk3308.The endoscope had 1985 uses remaining after the last procedural use.A review of the site's complaint history does not show any additional complaints related to this product.No image or video was provided for review.This complaint is being reported due to the following conclusion: during failure analysis testing, the xi endoscope was found to have damaged camera instrument adapter (aea) component.A damaged camera adapter results in poor camera control, which could result in unintuitive motion and subsequent tissue damage.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 patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is not applicable because the product is not implantable.Pma/510(k) number and adverse event are not applicable.
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It was reported that during central processing, the endoscope had a plastic gear and bearing broke off.There was no report of patient involvement.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.
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