Catalog Number C-VH-1111 |
Device Problem
Air Leak (1008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/30/2017 |
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 preparation for an endoscopic vein harvesting procedure, that there was an air bubble in the bom 7 mm extended length endoscope.The hospital did not report any patient effects.
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Manufacturer Narrative
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(b)(4).Initial reporter name: (b)(6).Email: (b)(6), internal complaint number: tw #(b)(4).Autonumber: # (b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The certificate of conformance (c of c) was not reviewed as the serial number was not reported.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, that there was an air bubble in the bom 7mm extended length endoscope.The hospital did not report any patient effects.
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Search Alerts/Recalls
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