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	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of today the investigation regarding this issue is still in-process.The system is being evaluated on-site and it is unknown if any parts will be returned for evaluation at this time.A follow-up will be filed as needed.
Event or Problem Description
It was reported by the fe that during a biopsy procedure the needle penetrated the patient breast and impacted the detector cover.The safety limit alarm did not inform the tech that the needle would hit the detector when fired.This was reported as no patient injury and it is unknown if the patient required any further medical attention.
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.

• 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: 7293976
• Report Number: 1220984-2018-00087
• Device Sequence Number: 16363112
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2018

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 02/23/2018
• 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