MAUDE Adverse Event Report: HOLOGIC, INC AFFIRM PRONE BIOPSY SYSTEM, 3D; BREAST BIOPSY SYSTEM

Model Number	PBX-SYS-AFFIRM-3D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of today, this investigation is still in-process and a follow-up will filed as needed.
Event or Problem Description
It was reported that during a preventative maintenance visit the field engineer noted the table and c-arm tend to randomly move up without anyone hitting the button.No injury reported.
Event or Problem Description
Additional information received from the field engineer noted that the footswitch on the system had previously been replaced for this issue.After further discussion with the customer it was determined that the issue had not returned after the footswitch was replaced and this issue may have been reported in error during the preventative maintenance visit.

• Brand Name: AFFIRM PRONE BIOPSY SYSTEM, 3D
• Common Device Name: BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 8488081
• Report Number: 1220984-2019-00030
• Device Sequence Number: 16773148
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: 15420045506510
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: PBX-SYS-AFFIRM-3D
• Device Catalogue Number: PBX-SYS-AFFIRM-3D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1