MAUDE Adverse Event Report: HOLOGIC, INC EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM; VACUUM ASSISTED CORE BIOPSY DEVICE

Model Number	EVIVA_0913-12T
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that during the procedure, the aperture would not close during biopsy mode.The tissue that was obtained was "too little and too thin." the procedure was completed with the little obtained tissue.The handpiece seems to have "low power suction" as commented by radiologist.Radiologist had to take the needle out of the patient breast while the aperture still open.A second device was not used.No additional details available.

• Brand Name: EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9307319
• Report Number: 1222780-2019-00251
• Device Sequence Number: 2460474
• Product Code: KNW
• UDI-Device Identifier: 25420045505336
• UDI-Public: (01)25420045505336(10)
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: EVIVA_0913-12T
• Device Catalogue Number: EVIVA_0913-12T
• Device Lot Number: 19D05RQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1