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

Model Number	STLC-00004
Medical Device Problem Codes	Imprecision (1307); Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy exam, the target appeared correct, but the needle was further in the breast.The biopsy was completed successfully and no injury reported.A field engineer was dispatched to the site and determined that recalibration was needed.Once this was completed, the system was working as intended.

• 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: 7828659
• Report Number: 1220984-2018-00141
• Device Sequence Number: 11214834
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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 Model Number: STLC-00004
• Device Catalogue Number: STLC-00004
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1