Catalog Number 8000.COM05 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.
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Event Description
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We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.
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Event Description
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We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.
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Manufacturer Narrative
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Review of the logfiles at the date of the reported event revealed some error messages but could not confirm the occurrence of the reported pum71.This error message is a clamping error which occurs when the minimum vacuum pressure for clamping is not reached within a set time.Unfortunately, the complaint cannot be further investigated nor confirmed as nothing was returned to d.O.R.C for investigation.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.All similar incidents related to the eva surgical system are included in the analysis (pd-defect-).Since 2020 more than (b)(4) surgeries have been performed with the eva surgical systems installed.Please note that the failure code pd-defect- will not always lead to a prolonged/delayed surgery.Please note that while the 2023 incident numbers are up to date, the 2023 installed base figures are from (b)(6) 2023.As in general the installed base increases, the actual number of devices in the market most likely is slightly higher.
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Event Description
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We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.
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Manufacturer Narrative
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The device will be returned but is not accessible for investigation yet.The investigation will be continued when the device is available for examination.
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Event Description
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We have been informed that during phaco procedure, while anesthesia was administered and incisions were made, it was noticed that the suction of the phaco handpiece did not work.Unable to solve the issue, it was decided to abort surgery and reschedule it to the next day.No report that actual patient harm occurred.
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Manufacturer Narrative
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In regard to this complaint, logfiles were provided for review and a pump module was provided for investigation.Review of the logfiles at the date of the reported event revealed some error messages but could not confirm the occurrence of the reported pum71 error.Visual inspection of the returned module revealed that the filter and sleeve broke off in the festo connectors, and functional inspection revealed a defective pneumatic valve inside the module.Due to the defective valve, the module could not pass priming and the eva surgical system was triggered to display the reported error message on the screen.Based on investigation results, it was determined that the reported complaint is attributable to a component failure of a pneumatic valve inside the pump module.The risk identified is included in the risk management documentation and the product is performing within anticipated rates.As an increased trend was detected a root cause analysis at the supplier has been requested (scar 2023-007).All similar incidents related to the eva surgical system are included in the analysis (pu-pneu-valve).Since 2021 more than 850.000 surgeries have been performed with the eva surgical systems installed.Please note that the failure codes will not always lead to a delayed surgery.Please note that while the 2023 and 2024 incident numbers are up to date, the installed base figures are from (b)(6)2023.As in general the installed base increases, the actual number of devices in the market most likely is higher.
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Search Alerts/Recalls
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