Model Number HST III SEAL (4.5MM), 5-PACK |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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).They inserted the heart string as usual and opened the umbrella, but he did not closely contact and could not stop the hemostasis.The hospital did not report any patient effects.
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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).They inserted the heart string as usual and opened the umbrella, but he did not closely contact and could not stop the hemostasis.The hospital did not report any patient effects.
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Manufacturer Narrative
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Corrected sections: b1-changed to adverse event & product problem.B2-changed to required intervention.H1-changed to serious injury.Trackwise # (b)(4).
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Manufacturer Narrative
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Trackwise # (b)(4).
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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).They inserted the heart string as usual and opened the umbrella, but he did not closely contact and could not stop the hemostasis.The hospital did not report any patient effects.
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Search Alerts/Recalls
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