MAUDE Adverse Event Report: HOLOGIC, INC. AFFIRM LATERAL ARM UPRIGHT BIOPSY ACCESSORY; BIOPSY GUDIANCE SYSTEM

Model Number ASY-09880

Device Problems Failure to Align (2522); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2017

Event Type  malfunction  

Event Description

During the initial biopsy applications training (prior to first patient use), our application specialist validated the spring loaded biopsy needle (bard magnum, non vacuum assisted biopsy device).To do this they followed a defined procedure using a targeting phantom (phantom with needle tip inside).At the end of the test, the tip of the biopsy needle needs to be aligned with the needle tip of the targeting phantom.During this validation process they have noticed the biopsy needle was not aligned with the targeting phantom.It was off for approx.2mm when the lateral arm was installed on the left hand side (blue side).

• Brand Name: AFFIRM LATERAL ARM UPRIGHT BIOPSY ACCESSORY
• Type of Device: BIOPSY GUDIANCE 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
• MDR Report Key: 6648560
• MDR Text Key: 77842980
• Report Number: 1220984-2017-00012
• Device Sequence Number: 1
• Product Code: IZH
• UDI-Device Identifier: 15420045506817
• UDI-Public: (01)15420045506817(11)160811(21)
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K161575
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service and Testing Personnel
• Device Model Number: ASY-09880
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1