MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D

Model Number	SDM-05000-3D3
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	06/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The logs were read and an investigation is ongoing.
Event or Problem Description
This mdr is a resubmit per request of (b)(6) which was received by hologic, inc.On (b)(6) 2020.During a stereo biopsy the technologist confirmed the coordinates for the needle position, then pressed the motor enable button to move the needle to the target, she said the unit beeped very quickly so she released the motor enable buttons.The technologist then numbed the patient breast and made an incision.Next she went to manually dial in the needle and noticed it was in the incorrect position.The technologist then retargeted and held the motor enable button longer and the needle went to the correct position so she then made a second incision and continued to do a successful biopsy.A fe reviewed the device logs and determined it was possible user error or switches going bad.When the customer retargeted and reset the coordinates, the machine worked as expected.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury, ct
• Manufacturer Contact: kelsea lyver ; 36 & 37 apple ridge road; danbury, ct
• MDR Report Key: 5873705
• Report Number: 1220894-2016-00019
• Device Sequence Number: 14155408
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: PO80003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2016

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
• Device Model Number: SDM-05000-3D3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2016
• Supplement Date Received by Manufacturer: 06/03/2016
• Initial Report FDA Received Date: 08/12/2016
• Supplement Report FDA Received Date: 08/12/2016
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown