Model Number EGIAADAPTXL |
Device Problem
Unintended Head Motion (1284)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/23/2018 |
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 robot assisted laparoscopic lobectomy, before entering the trocar which was not on the patient and when the reload was placed, there were two devices that started to calibrate, started spinning and would not stop after the adapter was taken off.A new powered stapler was used to complete the case.There was no patient injury in this event.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.No visual abnormalities were noted.The electrically erasable programmable read-only memory (eeprom) was uploaded and indicated 22 autoclave cycles for the adapter.A pmv representative sulu was inserted onto the adapter with a pmv drive handle and battery.The green light signaling the attachment of the adapter illuminated indicating that the adapter was recognized.The reload cycled properly and was applied to test media where it was able to apply the staple line and transect the media without difficulty.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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