Model Number TABLETOP |
Device Problem
Gas/Air Leak (2946)
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Patient Problems
Retinal Injury (2048); Loss of Vision (2139)
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Event Date 05/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A physician reported that after a pars plana vitrectomy (ppv) surgery, a patient experienced vision loss and visual scotoma.The patient developed a blind spot in the infero temporal with damage to the retinal ganglion cell layer supero-nasal.The patient did not receive expansile gas.The patient underwent a fluid air exchange and the surgeon was suspecting the way the air was introduced into the eye could have caused or contributed to the scotoma.No system message was displayed.The patient issues were not resolved, still had blind spot.
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Manufacturer Narrative
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The customer did not request service for the system.No sample has been received.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is:(b)(4).
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Manufacturer Narrative
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The manufacturer internal reference number is: (b)(4).
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Event Description
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Further review of the reported event has clarified that the air flow from the infusion cannula during the air-gas exchange, angled directly towards the superior nasal paracentral retina may have contributed to the patient's visual scotoma.
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Search Alerts/Recalls
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