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 08/02/2019 |
Event Type
malfunction
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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 evaluated by manufacturer? 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), 5-pack, they inserted the heart string as usual and opened the umbrella, but i couldn't stop bleeding because it was not in close contact, and i couldn't secure the field of view of the operative field.It was finally clamped.
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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), 5-pack, they inserted the heart string as usual and opened the umbrella, but i couldn't stop bleeding because it was not in close contact, and i couldn't secure the field of view of the operative field.It was finally clamped.
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Manufacturer Narrative
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Internal complaint number: (b)(4).The device was discarded.
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Search Alerts/Recalls
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