MAUDE Adverse Event Report: HOLOGIC, INC EVIVA 0913-12; INSTRUMENT, BIOPSY

Model Number EVIVA_0913-12

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

A device history record (dhr) review was conducted for the reported lot/serial number.The device was released meeting all qa specifications.A field engineer examined the equipment console, and it was determined that the user had made an error while selecting the size of the needle, they selected a needle much shorter in the software than the one installed which resulted in the error in the safety margin and why the needle went through the breast.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.

Event Description

It was reported that during an eviva procedure on (b)(6) 2023, during the tissue acquisition the post fire position was fired with such force that it passed the biopsy parameters set and through the patient´s breast.A third needle was used to complete the procedure.A field engineer examined the equipment, and it was determined that the user had made an error while selecting the size of the needle, they selected a needle much shorter in the software than the one installed which resulted in the error in the safety margin and why the needle went through the breast.

• Brand Name: EVIVA 0913-12
• Type of Device: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 18459630
• MDR Text Key: 332261887
• Report Number: 1222780-2024-00008
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVIVA_0913-12
• Device Catalogue Number: EVIVA_0913-12
• Device Lot Number: E23G05R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other