Model Number TABLETOP-JAPAN |
Device Problems
Complete Blockage (1094); Suction Problem (2170)
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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.A product sample has been shipped; however, it has not been received for evaluation at the manufacturing site.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that the tip was clogged and aspiration failure occurred during a procedure.The surgery was completed after replacing the product with another one.There was no patient harm.
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Manufacturer Narrative
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No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.The phaco tip was visually inspected and deemed conforming.A functional flow test was performed through the inside diameter of the sample to check for any obstructions.The test was deemed nonconforming, the phaco tip is partially occluded with a dripping outcome from the water flow check.The complaint evaluation confirm the phaco tip is occluded.The phaco tip did not pass the flow check test.The source and location of the occlusion cannot be determined from this evaluation, because no occlusion was observed during visual inspection.How and when the phaco tip became occluded cannot be determined from this evaluation.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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