Catalog Number 8065750517 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/26/2018 |
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.The manufacturer internal reference number is: (b)(4).
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Event Description
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A facility reported that the sleeve was twisting during the irrigation-aspiration step of a cataract procedure.The procedure was completed.There was no patient harm reported.According to the surgical equipment manager, it was determined that the surgeon was inadvertently winding the irrigation sleeve too far distally and causing the sleeve to bunch up behind the flared part of the polymer tip.A short in-service resolved the issue with no further incidents so far.This is one of three reports received from this facility.
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Manufacturer Narrative
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There have been no additional complaints reported against the finish goods lot and the device history record shows the product was released per specifications.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.The surgical account manager stated that the surgeon was inadvertently winding the irrigation sleeve too far distally and caused the sleeve to bunch up behind the flare part of the polymer tip.After a short in service the issue was resolved.The root cause of the customer's complaint was caused by the surgeon inadvertently winding the irrigation sleeve to far on the polymer tip cause the sleeve to twist or bunch up on the tip.The issue was resolved after a short in service was done with the surgeon.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time.Quality assurance will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.Consumables manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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