Model Number 176645 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/05/2018 |
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, pre-operatively, the jaws were not aligned with the tip.There was no patient involvement.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of devices.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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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Event Description
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According to the reporter, pre-operatively of hemicolectomy, the jaws were not aligned in the tip.There was no patient involvement.
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Search Alerts/Recalls
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