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Model Number 2000 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.We are currently unable to establish a relationship between the device and the issue reported.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
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Event Description
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It was reported that on april 16th during a novasure procedure, after the ablation, the physician noticed that the array was torn and performed an hysteroscopy and observed an incomplete ablation.No harm to the patient was reported.No other information is available.
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Manufacturer Narrative
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Novasure disposable was received and tested.Visual inspection was performed, and the tubing had no kinks, and all connections were secure.The array showed a hole and damage due to use.The external sheath was bent.The device did not come with the desiccant.Biologic material (blood and tissue) was present in the external sheath and the cervical collar.The device passed functional testing up until the ablation test that failed due to the hole in the mesh.The device was damaged and couldn´t work as intended.The complaint was confirmed.A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.
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Search Alerts/Recalls
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