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

Model Number PBX-SYS-AFFIRM-3D

Device Problem Poor Quality Image (1408)

Patient Problem Not Applicable (3189)

Event Date 12/01/2017

Event Type  malfunction  

Event 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
• Type of Device: BREAST BIOPSY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: debra rosenberg ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2032074512
• MDR Report Key: 7155131
• MDR Text Key: 96061259
• Report Number: 1220984-2017-00293
• Device Sequence Number: 1
• Product Code: IZH
• UDI-Device Identifier: 15420045506510
• UDI-Public: 15420045506510
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2017
• 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