Catalog Number 8065752918 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
No Code Available (3191)
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Event Date 08/16/2017 |
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 was received at the manufacturing site and it is awaiting evaluation.(b)(4).
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Event Description
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A customer reported that a piece of sleeve broke off and fell into the eye during an eye surgery with suspicion that it is still in the eye.No patient harm reported.A product sample and additional information has been requested for this report.No additional information has been received at this time.
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Manufacturer Narrative
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A device history review (dhr) indicates that the order was built to specifications.The returned sample was visually inspected and the issue was confirmed, a hole was found in the shaft of the infusion sleeve.The damage appears to have what resembles phaco tip piercing damage at the center section of the shaft.The root cause of the customer¿s complaint is most likely related to user handling during set-up.The marks on the sleeve have what resembles phaco tip damage; when the sleeve was installed over the phaco tip and the tip pierces the sleeve.(b)(4).
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Manufacturer Narrative
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Date received by mfg) for smdr 1 (mfg report num: 1644019-2017-00717) is 11/14/2017.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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