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

Model Number	0913-20
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been 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, a plastic introducer sheeth of the device was shredded.As indicated, the device test and the biopsy procedure were all successfully performed.However, when the physician wanted to remove the biopsy device at the end of the procedure, she felt resistance.Then by pulling it out with power, the plastic introducer sheeth was damaged and broken at its end.As reported, no patient harm, injury or impact did occur.

• Brand Name: EVIVA STEREOTACTIC BREAST BIOPSY SYSTEM
• Common Device Name: BREAST BIOPSY NEEDLE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7910206
• Report Number: 1222780-2018-00213
• Device Sequence Number: 19316909
• Product Code: KNW
• UDI-Device Identifier: 25420045505329
• UDI-Public: 25420045505329
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2018

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: Health Professional
• Device Expiration Date: 01/10/2019
• Device Model Number: 0913-20
• Device Catalogue Number: EVIVA 0913-20
• Device Lot Number: 17A10RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1