Model Number T.W. POWER SUPPLY |
Device Problem
Failure to Deliver Energy (1211)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/23/2020 |
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 during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) power cutout after 30-45 minutes of use.Vein was burned in-situ when being taken endoscopically.They had to take gsv from the other leg in order to do bypass.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(6) power cutout after 30-45 minutes of use.This case was completed by opening a new kit and the equipment worked afterwards.
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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 lot 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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