MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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Model Number VH-4000 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vessel harvesting procedure, vasoview hemopro 2 c-ring was bent in a way that interfered with cautery jaws and branch ligation could not be performed.2nd kit was opened and procedure was completed without further issue.There was a procedural delay as it required opening a new kit which delayed the harvest, as well as withdrawing the scope carefully to not create any injury.There was no harm to patient.Related to tw (b)(4).
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Manufacturer Narrative
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(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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N/a.
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Manufacturer Narrative
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Trackwise #: (b)(4).The lot # 3000371260 history record review was completed.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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