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

Model Number	PBX-SYS-AFFIRM-3D
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	12/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they were getting grey and washed out images causing the patient to be re-exposed.They rebooted the system and were able to get good images.Since the reboot of the system they have had no problem.

• 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: 7155131
• Report Number: 1220984-2017-00293
• Device Sequence Number: 1497616
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: 15420045506510
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153486
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

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: Radiologic Technologist
• Device Model Number: PBX-SYS-AFFIRM-3D
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 12/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1