MAUDE Adverse Event Report: HOLOGIC, INC. EVIVA STEROTACTIC GUIDED BREAST BIOPSY SYSTEM; BIOPSY INSTRUMENT

Model Number	EVIVA_1213-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.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 a biopsy procedure it was difficult to remove the needle.When the needle was removed it was noted to be bent.The patient felt discomfort during the removal.Additional information received noted, "patient outcome is unknown at this stage.She has not yet received her results so i don't know the extent of any bruising.".

• Brand Name: EVIVA STEROTACTIC GUIDED BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11020605
• Report Number: 1222780-2020-00172
• Device Sequence Number: 3595174
• Product Code: KNW
• UDI-Device Identifier: 25420045504995
• UDI-Public: (01)25420045504995(10)19G30RP
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• PMA/510(K) Number: K180233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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: 07/29/2021
• Device Model Number: EVIVA_1213-20
• Device Catalogue Number: EVIVA_1213-20
• Device Lot Number: 19G30RP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1