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 10/06/2023 |
Event Type
malfunction
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoviewhempro vh-3500 harvesting tool is getting stuck in cannula and is very difficult to advance.Case delayed.No harm to patient.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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Tw id# (b)(4).The lot # 3000324397 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 not returned.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, vasoviewhempro vh-3500 harvesting tool is getting stuck in cannula and is very difficult to advance.The same device was used to complete the procedure.Case delayed.No harm to patient.
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Search Alerts/Recalls
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