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

Model Number	EVIVA_1213-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Intraoperative Pain (2662); Breast Discomfort/Pain (4504)
Date of Event	02/01/2021
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, after taking several specimen, the patient complained of pain in the breast and the samples being cut were smaller than before.After drawing the needle back and out of the breast, the tip of the needle was noted to be "bent or even twisted." no serious injury reported and no medical intervention was required.This event occurred in (b)(6) 2021, but was not reported by the customer to hologic until (b)(6) 2021.
Additional Manufacturer Narrative
Eviva disposable received and tested , visual inspection was performed, the disposable looked as intended, no kinks were found in the tubings, nor cracks or damage in the disposable and no missing components.Functional testing was also performed, the device passed set up and test, passed biopsy test, saline was visible and canula was capable of being fired 5 times with the remote valve.Inner cannula was able to open and close and the device sounded as usual.No leaks were found and suction worked as intended.Tissue acquisition test was performed and the device worked as intended.Hence the complaint can not be confirmed.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.

• Brand Name: EVIVA STEREOTACTIC GUIDED BREAST BIOPSY SYSTEM
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 11611180
• Report Number: 1222780-2021-00068
• Device Sequence Number: 16959632
• Product Code: KNW
• UDI-Device Identifier: 35420045504992
• UDI-Public: 35420045504992
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2021

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: 04/23/2021
• Device Model Number: EVIVA_1213-20
• Device Catalogue Number: EVIVA_1213-20
• Device Lot Number: 19D24RT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown