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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 08/12/2021 |
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 preparation for an endoscopic vein harvesting procedure, t.W.Power supply s/n (b)(4) is not working.Intermittent power and intermittent energy delivery.The problem was discovered in testing prior to procedure, and was traced back to a loose connection inside the 110 volt socket for the ac cord.No patient effects.Warranty expired dec/10/2016.
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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: g4, g7, h2, h6, h10.Analysis of production for oem devices: (3331/213/67) the reported device is an oem device.The certificate of conformance was reviewed for the reported serial number.The vendor certifies that this device serial/lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.Historical data analysis: (4109/213/67) the review of the historical data indicates that no other similar complaints was reported for the same serial number and reported failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period sept 2019 through aug 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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Search Alerts/Recalls
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