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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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure the t.W.Power supply stopped heating and beeping when activated.The unit wouldn¿t work in multiple cases despite changing out cords.Only switching out units allowed for a functioning system.No added incision.Time was added was to the case to troubleshoot.No patient harm done.
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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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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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Event Description
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N/a.
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Search Alerts/Recalls
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