MAUDE Adverse Event Report: HOLOGIC, INC. ATEC; VACUUUM ASSISTED CORE BIOPSY DEVICE

Model Number	ATEC SAPPHIRE25
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the "unit starts procedure without customer engaging the footswitch." no injury reported.The issue was identified prior to starting a patient biopsy and the biopsy was successfully completed using another unit.It was determined that the footswitch needed to be replaced.Once this was completed the system was working as intended.

• Brand Name: ATEC
• Common Device Name: VACUUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8487961
• Report Number: 1222780-2019-00077
• Device Sequence Number: 2689150
• Product Code: KNW
• UDI-Device Identifier: 15420045504288
• UDI-Public: 15420045504288
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: Health Professional
• Device Model Number: ATEC SAPPHIRE25
• Device Catalogue Number: ATEC SAPPHIRE25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2019
• Initial Report FDA Received Date: 04/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1