Catalog Number C-VH-1111 |
Device Problem
Material Integrity Problem (2978)
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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 been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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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 lens was cloudy.
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Manufacturer Narrative
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On (b)(6) 2017 12:27 pm (gmt-4:00) added by (b)(6): 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.On (b)(6) 2017 08:13 am (gmt-4:00) added by (b)(6): internal complaint number trackwise # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.No visual defects were observed.An image quality inspection was performed with an endoscopic video imaging system.A cloudy and blurry image was obtained.The lens was cleaned and the image quality inspection was repeated.The image remained cloudy and blurry which suggests the issue with the lens.Based on the results of the evaluation, the reported complaint was confirmed for the reported failure "poor quality image".Specific actions for the confirmed failure mode are being maintained and documented under maquet¿s failure investigation report (fir) system.
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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 lens was cloudy.
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Search Alerts/Recalls
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