Catalog Number 8065751763 |
Device Problems
Device Inoperable (1663); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/23/2018 |
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 that a handpiece did not work in the eye during a cataract extraction procedure.The handpiece passed the prime/tune.When the surgeon went to use on the patient system messages were displayed requesting to change handpiece, change tip, tune.The surgeon was not able to re-tune the handpiece.The case was completed using an alternate handpiece.Patient harm was not confirmed.
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Manufacturer Narrative
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Corrected information has been provided.The initial decision to report was incorrect resulting in the initial report being submitted in error. 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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Search Alerts/Recalls
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