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Model Number T.W. POWER SUPPLY |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2021 |
Event Type
malfunction
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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.Device not returned.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, t.W.Power supply knob is missing.They are forced to use power supply without the knob, no injury.
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Manufacturer Narrative
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Trackwise #(b)(4).Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period (b)(6) 2019 through (b)(6) 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.
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Event Description
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N/a.
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Search Alerts/Recalls
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