MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Model Number	STLC-00004
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of today the investigation regarding this issue is still in-process.The returned parts are being evaluated.A follow-up will be filed as needed.
Event or Problem Description
It was reported that the z axis was off and during a biopsy procedure the needle went through the patient breast.It was noted that the imaging during the biopsy was off from the intended target.It was not realized that the needle had gone through the patient breast until after the case when the tech noticed a "small nick" on the medial side of the breast when the biopsy needle site was on the lateral side.No medical intervention was needed.The affirm upright system and breast tray were replaced.
Additional Manufacturer Narrative
Based on a health risk assessment that was completed no remedial action was necessary.The preventative action will be to replace any bgm pcb manufactured prior to a revision change in april 2016, this will be completed during the next site visit or if symptoms present prior to that.Parts were returned and evaluated by sustaining engineering.The issue was not reproduced during testing, however, based on the manufacturing date and the pcb version installed, it was determined to be consistent with a pcb issue.

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
• Common Device Name: BIOPSY GUIDANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 7294176
• Report Number: 1220984-2018-00088
• Device Sequence Number: 957759
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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: Radiologic Technologist
• Device Model Number: STLC-00004
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1