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Model Number 176645 |
Device Problems
Failure to Align (2522); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2018 |
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 laparoscopic cholecystectomy procedure, while in the beginning of the surgery during dissection, the grasp or shears did not close or clinch properly, the handles did not bind and the jaws appeared to be mal-aligned.A new product was opened to complete the case.There was no patient injury.
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Manufacturer Narrative
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Evaluation summary: 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.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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