Model Number 173016 |
Device Problem
Break (1069)
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Patient Problem
Radiation Exposure, Unintended (3164)
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Event Date 06/27/2019 |
Event Type
Injury
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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 repair on a sacrospinous stitch and anterior/posterior vaginal repair, half of the needle broke and feel into the patient¿s cavity.It was stated that an x-ray was performed to locate the component and a magnet was used but half of the needle was not found.The surgeon opted to finish the procedure.
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Manufacturer Narrative
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Evaluation summary: post market vigilance (pmv) led an evaluation of one device.Visual inspection of the returned instrument noted that there were no a bnormalities that would have caused or contributed to the reported condition.In addition (pmv) performed a photographic evaluation of five images of an instrument and the visual inspection of the returned photos noted that the instrument jaws were open and the blades were advanced.The instrument packaging and label was observed in the returned image.The returned instrument was found to function properly and the test needle remained intact and engaged throughout the testing process.No difficulty was experienced in loading, unloading or toggling the test needle in the returned instrument.Records from each manufacturing lot are thoroughly reviewed to ensure that products are 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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Search Alerts/Recalls
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