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 06/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Trackwise id# (b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.
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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) failed to work during a vein harvest.They were doing a vein harvest and when they tried to cauterize a branch the generator did not work.They then replaced the vh-3010 (generator with another one and it worked.They did not replace the cord.There was no issues with the vein and no adverse affects occurred because of it.
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Manufacturer Narrative
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Trackwise # (b)(4).Analysis of production: (3331/213/67) the reported device is an oem device.The certificate of conformance was reviewed for the reported serial/lot number.The vendor certifies that this device serial 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 jul 2019 through jun 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.Device not returned: (4114/ 213/67/3221) despite request and/ or customer indicated that the device would be returned; however, no device was returned.
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Search Alerts/Recalls
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