Catalog Number ARS655200 |
Device Problems
Mechanical Problem (1384); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This is the final report submitted regarding this surgical event and medical device.
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Event Description
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Revive locking caps x2 would not thread into place during this case.Surgeon worked on it for roughly 30 minutes starting over and putting it back together with the same result.The patient needed additional anesthesia to allow for the doctor to finish.
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Event Description
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Revive locking caps x2 would not thread into place during this case.Surgeon worked on it for roughly 30 minutes starting over and putting it back together with the same result.The patient needed additional anesthesia to allow for the doctor to finish.
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Manufacturer Narrative
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This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or is related to a death or injury.- attachment: [comp-2019-2891 investigation summary mdr.Pdf].
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Search Alerts/Recalls
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