MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VASOVIEW HEMOPRO 2 |
Device Problems
Electrical /Electronic Property Problem (1198); Smoking (1585); Environmental Particulates (2930)
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Patient Problems
No Consequences Or Impact To Patient (2199); Blood Loss (2597)
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Event Type
Injury
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Manufacturer Narrative
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Trackwise id# (b)(4).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 an endoscopic vein harvesting procedure using vasoview hemopro 2.The device shut down and stopped activating for 1-2 minutes.After this time, the device worked for a few seconds, then stopped working again and smoke was coming out at the tip of the jaw.Case was completed successfully but a new kit needed to be used to complete the case.Patient experienced bleeding during and after the procedure.The bleeding was then stopped through tamponade pressure.
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Event Description
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The hospital reported, that during an endoscopic vein harvesting procedure using vasoview hemopro 2.The device shut down and stopped activating for 1-2 minutes.After this time, the device worked for a few seconds, then stopped working again and smoke was coming out at the tip of the jaw.Case was completed successfully, but a new kit needed to be used to complete the case.Patient experienced bleeding, during and after the procedure.The bleeding was then stopped through tamponade pressure.
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Manufacturer Narrative
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Updated sections: g4, g7, h2, h6, h10.Corrected sections h-6 - device code changed; patient codes changed.Trackwise # (b)(4).A lot history record review was completed for lots (b)(4) and (b)(4).The last 3 lots shipped to the account prior to the event/aware date.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined, that there is no relation between the batch manufacturing process and the reported failure.
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Search Alerts/Recalls
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