MAUDE Adverse Event Report: HOLOGIC, INC ATEC EMERALD; INSTRUMENT, BIOPSY

Model Number	RM-ATEC EMERALD
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.A follow up report will follow with the information from the dhr.
Event or Problem Description
It was reported by the user site that during an atec emerald procedure on (b)(6) 2025, the "retest handpiece light came on during procedure after several samples acquired, system lost suction.Site switched out handpiece, tried petite handpiece as well, unable to complete setup.Procedure completed with existing samples." additional information was received from the user site, indicating "the patient was accessed for 2 separate biopsies of the same breast, and the machine quit working when taking samples of the first access.The radiologist was able to collect half of the samples on the first access for this patient." no further information available.

• Brand Name: ATEC EMERALD
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: dara smithers ; 600 technology drive; newark, DE 19702
• MDR Report Key: 23926993
• Report Number: 1222780-2025-00659
• Device Sequence Number: 8825319
• Product Code: KNW
• UDI-Device Identifier: 15420045506848
• UDI-Public: 15420045506848
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RM-ATEC EMERALD
• Device Catalogue Number: RM-ATEC EMERALD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown