Intuitive surgical, inc.(isi) received the 30 degree endoscope plus involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation confirmed the customer reported complaint.The returned endoscope had a bearing friction issue and discoloration of the housing.No image or video was available for review.A review of the 30 degree endoscope (part number 470057-08/sequence number 971814) associated with this event has been performed.Per the review, the 30 degree endoscope was last used in a procedure on (b)(6) 2022 on system (b)(4).The alleged instrument had 1873 uses remaining after the last procedural use.This was considered a reportable event due to the following conclusion: it was alleged that, the 30 degree endoscope plus was defective.It was unknown if a fragment fell into the patient and is unknown if tests were performed to attempt to locate the fragment.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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It was reported that the 30 degree endoscope plus was defective.It was unknown if a fragment fell into the patient.There was no report of patient injury.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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