Catalog Number 8267.VIT25 |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned to the manufacturer for investigation.
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Event Description
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We were informed that a bubble inside the cannula was identified during an operation.The operation was completed with another device and no actual patient harm occurred.
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Manufacturer Narrative
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The device has been returned to the manufacturer for investigation.Investigation is ongoing.No corrective or preventive actions can be implemented until the investigation has been completed.
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Event Description
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We were informed that a bubble inside the cannula was identified during an operation.The operation was completed with another device and no actual patient harm occurred.
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Event Description
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We were informed that a bubble inside the cannula was identified during an operation.The operation was completed with another device and no actual patient harm occurred.
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Manufacturer Narrative
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The device has been returned to the manufacturer for investigation.No corrective or preventive actions can be implemented until the investigation has been completed.With regard to this complaint, one vitrectome received for investigation.According to the complaint description from the customer, "a bubble was found inside the cannula".However, the received vitrectome was returned in an unopened pouch and was never used.Since the vitrectome that was returned for investigation was not used, the reported event cannot be attributed to the device that was provided for investigation.The customer was informed of the situation.Currently the investigation is pending the availability of the product subject to the reported event.
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Manufacturer Narrative
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With regard to this event, one tdc cutter in an unopened packaging was returned for investigation related to this complaint.However, based upon inquiry to obtain additional information from the customer, we became aware that the actual device used during the event was returned/investigated under a different reference number.Visual inspection of that vitrectome revealed that the body of the received product was slightly cracked, no functional testing was performed at that time.Due to the mix-up the product was discarded after closure of the related complaint and as such the actual product was no longer available for functional testing to investigate the cause of the reported event.Since a functional test could not be performed, it can not be confirmed that the reported bubble is attributable to a malfunction of the vitrectome that was returned for investigation.It is may be possible that the reported bubble was caused by the observed cracks however, this could not be confirmed conclusively.Typically a cracked body would result in a non-functional cutter.A database search showed that no similar complaints have been reported on this specific lot previously.In addition, review of the complaint database 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.
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Event Description
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We were informed that a bubble inside the cannula was identified during an operation.The operation was completed with another device and no actual patient harm occurred.
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Search Alerts/Recalls
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