Catalog Number 8065751763 |
Device Problems
Complete Blockage (1094); Suction Failure (4039)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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 during multiple cataract procedures, no aspiration occurred during phacoemulsification.The occlusion alarm sounded during the cases.All surgeries were completed without patient harm.
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Manufacturer Narrative
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The company service representative examined the system and was not able to replicate the reported event.Unrelated to the reported event, the nonconforming footswitch charger printed circuit board (pcb) was replaced to address a footswitch charging issue.Preventive maintenance (pm) was performed.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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