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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of today the investigation is still in process.A follow up will be submitted as needed.
Event or Problem Description
It was reported that during a biopsy exam, the c-arm released while the needle was in the patient's breast.No injury reported.The patient did not require additional patient care than the normal patient care post vacuum biopsy.
Additional Manufacturer Narrative
As of today the investigation is still in-process.We are awaiting the final resolution and part return for evaluation.A supplement will be filed as needed.
Event or Problem Description
The field engineer worked with technical support and it was determined that the detent bracket, dc motor, and spring needed to be replaced.Once this was completed the system was working as intended.

• 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: 7784630
• Report Number: 1220984-2018-00135
• Device Sequence Number: 136249
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: 15420045506510
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2018

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: PBX-SYS-AFFIRM-3D
• Device Catalogue Number: PBX-SYS-AFFIRM-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 10/03/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/12/2018; 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1