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

Model Number	ASY-09880
Medical Device Problem Codes	Failure to Align (2522); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2017
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: BIOPSY GUDIANCE SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 6648534
• Report Number: 1220984-2017-00010
• Device Sequence Number: 1082412
• Product Code: IZH
• UDI-Device Identifier: 15420045506817
• UDI-Public: (01)15420045506817(11)160908(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K161575
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date (Section B): 04/07/2017

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1