Model Number 100254CSSR-V-A1-CN |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/10/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device has not been returned to the manufacturer for evaluation.A root cause cannot be determined.
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Event Description
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It was reported that during inspection of the device prior to use in the patient, the "zebra" marks (coil exit marker) on the proximal end of the delivery pusher was noted to be missing.The device was not used in the patient.
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Manufacturer Narrative
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The device was received with the warning mark on the hypotube 62cm from the proximal gold connector, which meets specification.Based on the investigation findings and available information, the reported complaint is unconfirmed.The device was received with the warning mark 62cm from the proximal gold connector, which is in specification.The root cause of the complaint cannot be determined.
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Search Alerts/Recalls
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