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

Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Codes	Hematoma (1884); Breast Discomfort/Pain (4504)
Date of Event	06/16/2026
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 during a breast biopsy with an atec sapphire device on or around june 16, 2026 that "the system failed to automatically lavage and inject lidocaine during an mri procedure.Unfortunately, this resulted in severe pain for the patient and caused a hematoma." customer outreach was performed to further clarify any required interventions, and if the procedure was successfully completed.No further information is available at this time.

• Brand Name: ATEC SAPPHIRE
• 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 dr; newark, DE 19702
• MDR Report Key: 25676808
• Report Number: 1222780-2026-00415
• Device Sequence Number: 17320326
• Product Code: KNW
• UDI-Device Identifier: 15420045504295
• UDI-Public: (01)15420045504295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 09/28/2026

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
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/28/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown