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

Model Number	0913-12
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
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.Currently unable to establish a relationship or impact to the reported observation.(b)(4).
Event or Problem Description
It was reported a physician completed an eviva breast biopsy on (b)(6) 2017 and had difficulty removing the device.When the plastic introducer sheath was removed there were some missing plastic parts.The physician then noted the plastic parts were located at the patient's incision hole.There was no harm to the patient.The patient was discharged home.
Additional Manufacturer Narrative
The returned device was received, and inspected.Only device body returned as the quad tube set was cut right at the cradle by facility.No introducer was returned with device as it was reported the introducer was not available due to nature of complaint; therefore complaint for introducer issue could not be verified.The root cause for reported issue is unknown.A new introducer was mounted on the returned device to verify outer cannula integrity without issue.This is being trended and monitored.

• 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: 7152413
• Report Number: 1222780-2017-00303
• Device Sequence Number: 16324366
• Product Code: KNW
• UDI-Device Identifier: 15420045505322
• UDI-Public: (01)15420045505322(10)16B08RC
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2017

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: Physician
• Device Model Number: 0913-12
• Device Catalogue Number: EVIVA 0913-12
• Device Lot Number: 16B08RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/28/2017
• Supplement Date Received by Manufacturer: 12/28/2017; 02/16/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 12/28/2017; 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1