Model Number VH-3500 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
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, vasoview hempro vh-3500 c-ring endo loop hole incomplete.A second device was used to complete the procedure, and there was no delay, or patient harm reported.
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Manufacturer Narrative
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Trackwise id (b)(4).The lot #3000331388 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.H3 other text : device discarded.
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Search Alerts/Recalls
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