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Model Number ATEC SAPPHIRE |
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 01/24/2024 |
Event Type
Injury
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Event Description
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It was reported that during an eviva procedure on (b)(6) 2024, the atec biopsy footpedal would not work after they had already scouted the lesion.The biopsy gun had already been fired inside the breast and they had to cancel the procedure.A second needle was attempted to be used and did not work but not on the patient.The procedure was cancelled at that moment.No other information available.
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Manufacturer Narrative
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Device history record (dhr) review was unable to be conducted for the device at the time of this report, a follow up with the information will follow.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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