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Model Number T.W. POWER SUPPLY |
Device Problems
Break (1069); Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id (b)(6).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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The hospital reported that the t.W.Power supply broke.When plugged in and turned on they get a green light but have no accessories to test it.The power supply was purported to not deliver power to the cutting device and thus was not cutting branches.The power supply and extension cable was changed mid procedure and the procedure was completed using the same harvesting kit.The power setting was set to 2.5.No harm to patient.
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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).Updated sections: b4, g4, g7, h2, h6, h10, h11.Corrected sections: h6--medical device problem code.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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