Model Number NS2013KIT |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).
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Event Description
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It was reported that the suresound uterine sounding device was used prior to a novasure endometrial ablation.After the ablation was completed the physician viewed the cavity and noted three pieces that had broken off of the suresound device.The physician was able to successfully removal all three pieces from the uterine cavity.
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Manufacturer Narrative
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As of today the reported device has not been returned for evaluation.If the device is returned a follow up will be filed as needed.
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Search Alerts/Recalls
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