MAUDE Adverse Event Report: HOLOGIC, INC ATEC SAPPHIRE25; INSTRUMENT, BIOPSY

Model Number	ATEC SAPPHIRE25
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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 that pre procedure set up testing was successfully completed on an atec sapphire25 breast biopsy system on (b)(6) 2026.However, the user reports that once the procedure was started, they were only able to obtain two samples before the "retest" indicator light on the atec console came on.It is reported that the user site removed the needle from the patient; however, the initial samples were inadequate, and a repeat procedure has been scheduled.Injury mdr submitted due to the need for a repeat procedure on the patient.

• Brand Name: ATEC SAPPHIRE25
• 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: 25148137
• Report Number: 1222780-2026-00230
• Device Sequence Number: 9351295
• Product Code: KNW
• UDI-Device Identifier: 15420045504288
• UDI-Public: 15420045504288
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: 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: 04/15/2026
• Initial Report FDA Received Date: 05/12/2026
• 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