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Model Number 176645 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/08/2018 |
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, laparoscopic cholecystectomy procedure, the tips or the jaw of the device were not aligned properly.As it was difficult to use, surgeon stopped using the device and opened another one to continue.There was no patient injury.
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Manufacturer Narrative
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Post market vigilance (pmv) led an evaluation of one device.Engineering verified that jaw alignment of device was within specifications.Engineering inspected jaws under a microscope and found no physical damage to the jaws.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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Search Alerts/Recalls
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