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

Model Number STLC-00004

Device Problem Power Problem (3010)

Patient Problem Bruise/Contusion (1754)

Event Date 07/09/2018

Event Type  malfunction  

Event Description

It was reported that errors were occurring during qc, but was able to eventually pass.During a patient biopsy the targets appeared correct, but when the needle was fired it went beyond the target to the other side of the breast.Bruising was noted.Pressure was applied to the area and no further medical intervention was needed.A field engineer was dispatched to the site and it was determined that the zenner diode was weak and needed to be jumped and the breast platform was replaced.Once this was completed the system was working as intended.Per the technologist a follow up call is made to patients the next day for results and she was not informed of any further issues.

• 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: 7758120
• MDR Text Key: 116386577
• Report Number: 1220984-2018-00127
• Device Sequence Number: 1
• Product Code: IZH
• UDI-Device Identifier: 15420045505858
• UDI-Public: 15420045505858
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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