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Model Number 311464-05 |
Device Problem
Component Missing (2306)
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Patient Problem
Blurred Vision (2137)
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Event Date 08/19/2015 |
Event Type
Injury
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Manufacturer Narrative
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The endoscope was returned to the original equipment manufacturer (oem) for evaluation.The endoscope was received with a missing distal window resulting in fluid invasion and subsequent damage to the optical components.Based on the information provided, this complaint is deemed reportable due to the following conclusion: after the da vinci surgical procedure, the lens of the endoscope was found to be missing.At this time, it is still unknown if the endoscope lens actually fell in the patient and was retained.The endoscope was returned, evaluated, and the lens was confirmed to be missing.
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Event Description
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It was reported that at the beginning of the da vinci prostatectomy procedure, the vision was blurry; however, the site decided to continue with the procedure.After the procedure was completed, the surgical staff removed the endoscope and noted that the distal lens was missing from the endoscope.The site performed multiple tests (echo, x-ray, and mri) on the patient to locate the missing lens since the site was unsure if the missing lens had fallen into the patient during the surgical procedure.As of the time of this report, it the location of the missing lens is unknown.
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Search Alerts/Recalls
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