Model Number T.W. POWER SUPPLY |
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 10/05/2022 |
Event Type
malfunction
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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.
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Event Description
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The hospital reported that prior to the start of the endoscopic vein harvesting procedure t.W.Power was not turning on.They swapped out cables and checked the indicator light and isolated the problem to the vh-3010 device.A different power supply unit was used for the case.No patient effects were reported.
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Event Description
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N/a.
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Manufacturer Narrative
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(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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