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

Model Number	1213-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal reference complaint#:(b)(4).
Event or Problem Description
It was reported the physician performed a breast biopsy procedure on (b)(6) 2018, and the physician had a lot of resistance and had a difficult time removing the needle from the breast.Then the needle was removed it was noted "twisted and bent" when removed.No patient injury reported.

• Brand Name: EVIVA STEROTACTIC BREAST BIOPSY SYSTEM
• Common Device Name: BREAST BIOPSY NEEDLE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7741882
• Report Number: 1222780-2018-00172
• Device Sequence Number: 1405147
• Product Code: KNW
• UDI-Device Identifier: 25420045504995
• UDI-Public: (01)25420045504995(10)17M05R
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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: No Information
• Device Expiration Date: 12/05/2019
• Device Model Number: 1213-20
• Device Catalogue Number: EVIVA 1213-20
• Device Lot Number: 17M05R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1