Catalog Number 8065750180 |
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 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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that the system displayed a system message and the phaco did not work.
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Manufacturer Narrative
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The company service representative examined the system and was able to replicate the reported event of the phaco not working.The top phaco port was nonconforming.The u/s handpiece cable assembly and the u/s controller printed circuit board (pcb) were replaced.The system was then tested and met all product specifications.The system was manufactured on december 16, 2004.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event of the phaco not working cannot be determined conclusively since multiple parts were replaced to address the reported event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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