Catalog Number C-VH-1111 |
Device Problem
Bent (1059)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, bom 7mm extended length endoscope bent during harvesting.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure, bom 7mm extended length endoscope bent during harvesting.The hospital did not report any patient effects.
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Search Alerts/Recalls
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