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Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Leak/Splash (1354)
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Patient Problem
Blood Loss (2597)
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Event Date 12/02/2019 |
Event Type
Injury
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Manufacturer Narrative
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Trackwise id# (b)(6).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.Device discarded.
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Event Description
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The hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).As usual, the main body was set and the umbrella was opened, but it was not hemostatic and the field of vision could not be secured.They inserted the heart string as usual and opened the umbrella, but couldn't stop bleeding because it was not in close contact, and couldn't secure the field of view of the operative field.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Trackwise id (b)(6).Updated sections: e1, g4, g7, h2, h3, h10.
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Event Description
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He hospital reported that during a coronary artery bypass procedure using hst iii seal (4.5mm).As usual, the main body was set and the umbrella was opened, but it was not hemostatic and the field of vision could not be secured.They inserted the heart string as usual and opened the umbrella, but couldn't stop bleeding because it was not in close contact, and couldn't secure the field of view of the operative field.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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