Model Number VASOVIEW HEMOPRO 2 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2022 |
Event Type
malfunction
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Event Description
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The hospital reported that during the branch management of an endoscopic vein harvesting procedure the vasoview hemopro 2, metal got separated from the silicon tip.After that, they completed the procedure with a new device.The jaws of the harvesting tool were not open (even slightly) during the insertion of the tool into the cannula.No resistance was noted.No procedural delay.No harm to the patient.
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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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Manufacturer Narrative
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Trackwise #(b)(4).The lot # 3000244417 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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N/a.
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Search Alerts/Recalls
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