|
Model Number BREVDISP09 |
Device Problem
Failure to Obtain Sample (2533)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/13/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that on december 13th, a biopsy procedure was performed, and during the procedure, two needles malfunctioned while they were in the patient's breast.The procedure was completed with another device.
|
|
Manufacturer Narrative
|
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.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 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.2 devices were involved in this event: 1222780-2023-00477.
|
|
Search Alerts/Recalls
|
|
|