Catalog Number 8000.COM05 |
Device Problem
Insufficient Flow or Under Infusion (2182)
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Patient Problem
Insufficient Information (4580)
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Event Date 07/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The complaint is under investigation.
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Event Description
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It was reported that an unstable iop was encountered during procedure.Due to this event the eye collapsed.No actual patient harm was reported.In addition, the issue encountered did not result in a prolonged or delayed surgery.
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Event Description
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It was reported that an unstable iop was encountered during procedure.Due to this event the eye collapsed.No actual patient harm was reported.In addition, the issue encountered did not result in a prolonged or delayed surgery.
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Manufacturer Narrative
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The complaint will be investigated based upon the logfiles.The surgical system and related consumables will not be returned for investigation.Investigation to determine the root cause of the reported event is ongoing.
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Manufacturer Narrative
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The complaint will be investigated, based upon the logfiles.The surgical system and related consumables will not be returned for investigation.Investigation to determine the root cause of the reported event is ongoing.Submission of this correction is, due to incorrect document upload when submitting follow up 1.
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Event Description
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It was reported, that an unstable iop was encountered, during procedure.Due to this event, the eye collapsed.No actual patient harm was reported.In addition, the issue encountered, did not result in a prolonged or delayed surgery.
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Manufacturer Narrative
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With regard to this event logfiles were provided for review.Review of the log files of the eva system involved revealed a possible issue with the supplied input air.As included in the eva instruction manual section a1.2 "eva environmental specifications" the requirements of the air input are specified to be 4 to 10 bar with a flow rate of 60 to 70 nl/min.During an on-site inspection, the pressure of compressed air and the manometer were checked and re-adjusted.This solved the problem.It should be noted that the issue persisted also on another eva system (case (b)(4).) and also for this eva the issue was solved after the pressure of compressed air and the manometers were re-adjusted.Review of the complaint database indicated that no similar issues have been logged on the eva surgical system subject to this event.Since the problem did not re-occur and no module was replaced, it is considered that the event was triggered due to a too low flow rate or pressure of the input air supplied by the hospital.
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Event Description
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It was reported that an unstable iop was encountered during procedure.Due to this event the eye collapsed.No actual patient harm was reported.In addition, the issue encountered did not result in a prolonged or delayed surgery.
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Search Alerts/Recalls
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