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Model Number 470057-08 |
Device Problem
Optical Distortion (3000)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/22/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a da vinci-assisted incisional hernia surgical procedure, the 30 degree endoscope had double vision.There was no reported 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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Manufacturer Narrative
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The 30 degree endoscope has not been returned to intuitive surgical, inc.(isi) for evaluation.If additional information is received, a follow-up mdr will be submitted.The 30 degree endoscope part# 470057-08/ lot/serial# (b)(4) was last used on (b)(6) 2022 on system (b)(4) with 1943 use remaining.No image or procedure video was provided for review.Based on the information available at this time, this complaint is being classified as a reportable event due to the following conclusion: it was reported that the endoscope displayed double vision.The issue was resolved through the use of a backup endoscope.Poor vision and/or camera control could result in tissue damage.At this time, the root cause of the failure is unknown.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.
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Event Description
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Refer to h10/h11 for follow-up information.
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Manufacturer Narrative
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Additional information found in: d9, g3, g6, h2, and h3 evaluation information found in: h6 and h10 the 30-degree endoscope has been returned and evaluated by the failure analysis team.Failure analysis could not replicate nor reproduce the reported issue.The image was good in both eyes.Sapphire distal window was found to be damaged/cracked.Camera adapter and scope had friction issues.
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Search Alerts/Recalls
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