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

Model Number	EVIVA_1210-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Intraoperative Pain (2662); Breast Discomfort/Pain (4504)
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, after taking 3-5 specimens, the patient complained of pain.When attempting additional samples the patient continued to have pain and the specimen passing the tube seemed to be smaller than usual.A control picture showed the deformed needle and a decision was made to stop the procedure.Difficulties in drawing the needle out of the breast.No serious injury reported and no medical intervention required.This event occured in (b)(6) 2020, 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 and it was found that the cannula was damaged.Hence the complaint can 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.After completing the review of the device history records, manufacturing process, related non conformances and capa's, it is concluded that the outer cannula twisted complaint are not manufacturing related, since there are not atypical conditions found during the manufacturing of these lots, additional all the complaints were reported from the same location (australia), and the other locations where the lots were also distributed did not reported any complaints related to the outer cannula twisted failure mode, for this reason the occurrence of the outer cannula twisting could be highly related to the use of the devices instead of failure modes occurred as a result of the manufacturing process.

• 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: 11611181
• Report Number: 1222780-2021-00070
• Device Sequence Number: 3262291
• 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_1210-20
• Device Catalogue Number: EVIVA_1210-20
• 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