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Model Number EVIVA_0913-20 |
Device Problem
Failure to Obtain Sample (2533)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/13/2023 |
Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2023, during an eviva procedure, the needle failed while inside the breast.The patient had to be rescheduled for a new procedure.The device was reported as discarded.No other information is available.
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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.H3: 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.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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Search Alerts/Recalls
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