Model Number EGIA60AMT |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a laparoscopic right hemicolectomy procedure, at resection of ascending colon cancer, at functional anastomosis.After the firings, the surgeon found a yellow broken piece in the cavity by the camera and was able to retrieve it.No patient injury was reported.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device with articulating medium/thick reload.Visual inspection of the returned product noted that the reload was fully fired.Functional evaluation of the reload found no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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