Catalog Number 8065750833 |
Device Problems
Disconnection (1171); Power Problem (3010)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/14/2019 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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A nurse reported there was no phacoemulsification (phaco) power and the tray arm cover was disjointed.Timing of the event and patient impact are unknown.Additional information has been requested.
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Manufacturer Narrative
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Additional information is provided based on this information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.The manufacturer internal reference number is: (b)(4).
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Event Description
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Additional information has been received confirming prior to the cataract extraction procedure the system showed little ultrasound power even after having passed the ultrasound test.The handpiece was immediately exchanged which did not resolve the issue.The case was completed using an alternate system.There was no patient involvement.
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Search Alerts/Recalls
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