Catalog Number OEM UNKNOWN |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Information (3190)
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Event Date 08/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.The device history review could not be conducted since the lot number was not provided.The complaint cannot be confirmed due the lack of a product sample and batch number to perform a proper investigation therefore the root cause is unknown.The manufacturer will continue to monitor and trend related events.
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Event Description
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The suture capturing device cut the suture off the bullet; on a second attempt it cut the bullet off and the bullet was stuck in the driver.The patient's condition was reported as unknown.
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Search Alerts/Recalls
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