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Model Number EGIA60AMT |
Device Problems
Failure to Advance (2524); Misfire (2532)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/11/2018 |
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, at the first firing of rectum resection in a laparoscopic proctectomy, they set the powered stapling device and the cartridge.They checked the jaws and the display screen with no problem.The surgeon started the firing, however, the knife stopped at the halfway.They pushed the center control button again; however, the knife did not advance.The display screen showed '0'.Replaced by a new cartridge and the firing was completed with no problem.The status of the patient was reported as no problem.
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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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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned product noted that the reload was partially fired with the interlock engaged.The jaws were open.There were staples protruding from proximal staple cartridge channel.Functionally the reload was loaded into a post market vigilance instrument, the interlock was over ridden, and the reload was applied to test media.All remaining staples were placed, and test media was cleanly transected.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Replication of the partial fire condition with interlock engagement may occur if the firing button had been partially compressed and then the open button was pressed after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the loading unit from firing a second time.The root cause of the observed damage was misuse of the product which caused or contributed to the reported condition.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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