MAUDE Adverse Event Report: HOLOGIC, INC. ATEC INSTRUMENT BIOPSY; BREAST BIOPSY DEVICE,

Model Number	ATEC 0912-20 HAND PIECE
Medical Device Problem Code	Decrease in Suction (1146)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.(b)(4).
Event or Problem Description
It was reported the physician performed an atec breast biopsy procedure on (b)(6) 2018, and the "specimen get sucked into the needle, no aspiration of these specimens and no possibility to have them collected into the chamber.When inserting the marker into the atec biopsy device it pushed specimens back into the breast".The procedure was completed successfully with a second device.No patient injury reported.

• Brand Name: ATEC INSTRUMENT BIOPSY
• Common Device Name: BREAST BIOPSY DEVICE,
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 7715673
• Report Number: 1222780-2018-00161
• Device Sequence Number: 1121334
• Product Code: KNW
• UDI-Device Identifier: 25420045504841
• UDI-Public: (01)25420045504841(10)17E03RC
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K010400
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: No Information
• Device Expiration Date: 05/03/2019
• Device Model Number: ATEC 0912-20 HAND PIECE
• Device Lot Number: 17E03RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1