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

Model Number	ATEC 1212-20
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that during a biopsy procedure after the device was inserted into the patient breast it was noted to be bent.No injury reported.The device was removed and a second device was used to successfully complete the biopsy.

• Brand Name: ATEC
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 11167232
• Report Number: 1222780-2021-00005
• Device Sequence Number: 19654691
• Product Code: KNW
• UDI-Device Identifier: 15420045505889
• UDI-Public: 15420045505889
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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 Expiration Date: 12/09/2021
• Device Model Number: ATEC 1212-20
• Device Catalogue Number: ATEC 1212-20
• Device Lot Number: 19M10RD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1