Model Number 7MM EXTENDED LENGTH ENDOSCOPE |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/12/2021 |
Event Type
malfunction
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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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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope was cloudy.No patient involvement.
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Manufacturer Narrative
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Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope was cloudy.No patient involvement.
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Event Description
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The hospital reported that during preparation for an endoscopic vein harvesting procedure, 7mm extended length endoscope was cloudy.No patient involvement.
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Manufacturer Narrative
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Trackwise # 431334.The reported device is an oem device.The certificate of conformance was reviewed for the serial # (b)(4).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.The device was returned to the factory for evaluation on 02/22/2021.An investigation was conducted on 03/15/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The endoscope was observed to be intact, no visual defects were observed.An image quality inspection was performed on 04/26/2021with an endoscopic video imaging system.A clear image was able to be obtained.The image was observed to clear with no visual defects observed.Based on the results of the evaluation, the reported failure "poor quality image" was not confirmed.
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Search Alerts/Recalls
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