Model Number BREVERA CONSOLE |
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 02/08/2024 |
Event Type
Injury
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Event Description
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It was reported that during a brevera procedure on (b)(6), 2024, the customer reported that a driver error was seen during the procedure.An incision had already been made on the breast and the procedure had to be cancelled and rescheduled.No other information is available.Console pending to be examined.
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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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Search Alerts/Recalls
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