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

Model Number 0913-20

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Method: visual inspection of the image confirmed a piece of foreign material was found inside of the biopsy samples.No further information is available at this time.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).

Event Description

It was reported a physician performed an eviva breast biopsy on (b)(6) 2017, and a piece of foreign material was found inside of the biopsy samples.The material was removed from the patient's breast and the procedure was finished successfully.No patient injury reported.

• Brand Name: EVIVA STEROTACTIC BREAST BIOPSY SYSTEM
• Type of Device: BREAST BIOPSY NEEDLE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sidra piracha ; 250 campus drive; marlborough, MA 01752 ; 5082638884
• MDR Report Key: 7534353
• MDR Text Key: 109118558
• Report Number: 1222780-2018-00096
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 15420045504974
• UDI-Public: (01)15420045504974(10)17J25RA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K042290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/25/2019
• Device Model Number: 0913-20
• Device Catalogue Number: EVIVA 0913-20
• Device Lot Number: 17J25RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1