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Model Number C-VH-3010 |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply not working properly, no power.Changed to another power supply to complete case.There was no effect on the patient and a minimal delay in completion of the evh.
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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.
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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 reported device is an oem device.The certificate of conformance was reviewed for the serial #(b)(6).The vendor certifies that this device serial # conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.
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Search Alerts/Recalls
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