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

Model Number	EVIVA_0913-12T
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Breast Discomfort/Pain (4504)
Date of Event	04/19/2021
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 when removing the probe to insert the site marker it was difficult to remove.The probe and introducer had to be removed together and a site marker was not able to be placed.Once removed it was noted the probe had been bent.The patient experienced pain during removal, but no medical or surgical intervention was required.

• Brand Name: EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11838588
• Report Number: 1222780-2021-00112
• Device Sequence Number: 19837931
• Product Code: KNW
• UDI-Device Identifier: 35420045505333
• UDI-Public: 35420045505333
• Combination Product (Y/N): N
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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: 11/24/2021
• Device Model Number: EVIVA_0913-12T
• Device Catalogue Number: EVIVA_0913-12T
• Device Lot Number: 19L25RA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1