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

Model Number STLC-00004

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned sample found that spring coupling, that joins the needle carriage assembly to the z-axis gears, had failed.This condition allowed the needle carriage assembly to freely fall, under the weight of needle carriage assembly and biopsy needle.Eco-39089 replaced the spring coupling issue on 01/29/2015.According to the dhr, the affirm upright in question was manufactured in may 2013 prior to the eco release.

Event Description

It was reported that when positioning the patient for a breast biopsy, the needle was approximately 3 to 5 cm above the skin before the mechanical part of the z-axis broke.The needle penetrated the patient breast approximately 2 to 3 cm deep through the area of the breast intended to be entered for the biopsy.The needle was manually removed and no medical intervention was needed beyond normal biopsy wound care.A field engineer was dispatched to the site and the affirm system was replaced and is working as intended.

• Brand Name: AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
• Type of Device: BIOPSY GUIDANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 8587902
• MDR Text Key: 145541237
• Report Number: 1220984-2019-00044
• Device Sequence Number: 1
• Product Code: IZH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2019

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
• Device Operator: Health Professional
• Device Model Number: STLC-00004
• Device Catalogue Number: STLC-00004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1