Model Number 173054 |
Device Problems
Failure to Fire (2610); Difficult to Open or Close (2921)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/29/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.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 procedure, the device was difficult/ unable to close and did not fire.They opened a new product to resolve the issue and complete the case.The patient is alive with no injury.
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Manufacturer Narrative
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Evaluation summary; post market vigilance (pmv) led an evaluation of the device.Visual inspection of the unit noted a staple jammed in the e-piece and the e-piece partially disengaged.The staple was removed and the unit was test fired.All remaining staples in the dlu deployed and seated properly.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Replication of the reported condition may occur as a result of a broken e-piece from excessive manipulation of the device.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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