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Model Number GN-283 |
Device Problems
Break (1069); Product Quality Problem (1506)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2018 |
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, prior to a procedure, when the nurse opened the package, the product was discolored and the thread broke easily.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.The visual inspection of the returned product noted two needles and two partial sutures in a retainer.The needles were observed to be attached to the partial sutures.The sutures were observed to have a discoloration; the sutures appeared to be a green brown color instead of its original color, black.Visual inspection of the needles noted no abnormalities.Because no sealed samples were returned, pmv cannot verify that the sutures were discolored before the sealed package was open/used.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 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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